Dilatation Ptca Balloon Catheter for PCI with CE Certificate
China Dilatation Ptca Balloon Catheter for PCI with CE Certificate, Find details about China Balloon Inflation Catheter, 3-Wings Balloon Fluting from Dilatation Ptca Balloon Catheter for PCI with CE Certificate
Basic Info.
Model NO.
PTCA
Application
Cardiovascular
Certification
CE, FDA, Kfda, Pmda, ISO13485
Nominal Burst Pressure
6 ATM
Rated Burst Pressure
16 ATM
Balloon Folding
3
Catheter Lengthcatheter Length
142cm
Trademark
Kossel, Global
Transport Package
Box or Pouch
Specification
Diameter from 1.0mm to 4.0mm
Origin
Suzhou China
HS Code
9018390000
Model NO.
PTCA
Application
Cardiovascular
Certification
CE, FDA, Kfda, Pmda, ISO13485
Nominal Burst Pressure
6 ATM
Rated Burst Pressure
16 ATM
Balloon Folding
3
Catheter Lengthcatheter Length
142cm
Trademark
Kossel, Global
Transport Package
Box or Pouch
Specification
Diameter from 1.0mm to 4.0mm
Origin
Suzhou China
HS Code
9018390000
Product Desciption
Company Profile
Kossel Medtech (Suzhou) Co., Ltd. with the headquarter in Suzhou China, was coestablished by experts in US and domestic R&D team in 2013. Kossel Medtech focus on R&D, manufacturing and sales of Class 3 interventional cardiovascular medical devices, including products for peripheral vess,elelectrophysiology,coronary and technical service.Kossel Medtech's main clients are overseas and domestic high-end medical devices manufacturers, distributors and hospitals.
Product Feature
1.The advanced laser bonding technology ensures the balloon and the catheter smooth transition connection,that makes better cross ability.
2.Tip laser forming technique makes the balloon with a small entrance ,which can enhance the performance of crossing the stenosis; Soft tapered tip is designed to enhance the traceability of the catheter with the guide wire.
3.The 3-wings balloon fluting ensure that the balloon have a minimum profile to easier cross the stenosis easier.
4.Super-lubricity hydrophilic coating design can offer a superior delivery performance.
5.The tapered core wire can offer excellent delivery performance.
Production Line
We have ten thousand level purification workshop, committed to the development of excellent quality products.
Certificate
FAQ
What types of products do you offer?
We offer wide range of vascular interventional and implantable products, including PTCA, NC PTCA, CTO, PTA, inflation device, radial artery tourniquet, diagnostic electrophysiology catheter, cardiac ablation catheter, and vena cava filter.
Do you have certificates for your products?
Our facility is ISO 13485 (medical device quality management system) certified. Some of products have CE marks and FDA approval. Other products are being registered at this moment. Please contact us to check if your demand products can be distributed in your market.
Would you send me free samples?
In most cases, we offer one or two samples for your evaluation. Please advise your express account number to get free samples.
What is your minimum order qty (MOQ)?
There is no MOQ required. One piece is okay to be shipped.
What is the payment terms?
100% T/T payment in advance.
What is the lead time?
It depends on products. Please contact us for details.
Do you provide OEM service?
Yes, please send us your drawings and specifications to make your own brand product.Are
Are your products sterilized?
Yes, all of our products are EO sterilized.
How do you ensure products' quality?
Quality is life. We have conducted raw materials inspection, in progress quality control, finished products and package inspection according to ISO 13485 requirements. QA & QC is deployed throughout all processes. This is to ensure products you receive has zero defect.
Contact information
Kossel Medtech (Suzhou) Co., Ltd. with the headquarter in Suzhou China, was coestablished by experts in US and domestic R&D team in 2013. Kossel Medtech focus on R&D, manufacturing and sales of Class 3 interventional cardiovascular medical devices, including products for peripheral vess,elelectrophysiology,coronary and technical service.Kossel Medtech's main clients are overseas and domestic high-end medical devices manufacturers, distributors and hospitals.
Product Feature
1.The advanced laser bonding technology ensures the balloon and the catheter smooth transition connection,that makes better cross ability.
2.Tip laser forming technique makes the balloon with a small entrance ,which can enhance the performance of crossing the stenosis; Soft tapered tip is designed to enhance the traceability of the catheter with the guide wire.
3.The 3-wings balloon fluting ensure that the balloon have a minimum profile to easier cross the stenosis easier.
4.Super-lubricity hydrophilic coating design can offer a superior delivery performance.
5.The tapered core wire can offer excellent delivery performance.
Balloon Compliance and Rated Burst Pressure
| P/atm D/mm | Tolerance of Compliance:±5% | ||||||
| 6 (NP) | 8 | 10 | 12 | 14 | 16 (RBP) | 18 | |
| 1.0 | 1.00 | 1.03 | 1.06 | 1.08 | 1.10 | 1.12 | 1.14 |
| 1.25 | 1.25 | 1.29 | 1.33 | 1.37 | 1.40 | 1.43 | 1.46 |
| 1.5 | 1.50 | 1.53 | 1.56 | 1.59 | 1.62 | 1.65 | 1.68 |
| 2.0 | 2.00 | 2.03 | 2.06 | 2.09 | 2.12 | 2.15 | 2.18 |
| 2.25 | 2.25 | 2.30 | 2.35 | 2.40 | 2.44 | 2.48 | 2.54 |
| 2.5 | 2.50 | 2.54 | 2.58 | 2.61 | 2.64 | 2.67 | 2.70 |
| 2.75 | 2.75 | 2.79 | 2.83 | 2.86 | 2.89 | 2.92 | 2.95 |
| 3.0 | 3.00 | 3.04 | 3.08 | 3.11 | 3.14 | 3.17 | 3.21 |
| 3.25 | 3.25 | 3.32 | 3.39 | 3.46 | 3.53 | 3.6 | 3.67 |
| 3.5 | 3.50 | 3.55 | 3.60 | 3.64 | 3.69 | 3.73 | 3.77 |
| 4.0 | 4.00 | 4.05 | 4.10 | 4.15 | 4.20 | 4.25 | 4.30 |
Size Matrix of PTCA Balloon Catheter
| L/mm D/mm | 10 | 15 | 20 | 25 | 30 |
| 1.0 | √ | √ | - | - | - |
| 1.25 | √ | √ | - | - | - |
| 1.5 | √ | √ | √ | √ | - |
| 2.0 | √ | √ | √ | √ | √ |
| 2.25 | √ | √ | √ | √ | √ |
| 2.5 | √ | √ | √ | √ | √ |
| 2.75 | √ | √ | √ | √ | √ |
| 3.0 | √ | √ | √ | √ | √ |
| 3.25 | √ | √ | √ | √ | √ |
| 3.5 | √ | √ | √ | √ | √ |
| 4.0 | √ | √ | √ | √ | √ |
Production Line
We have ten thousand level purification workshop, committed to the development of excellent quality products.
Certificate
FAQ
What types of products do you offer?
We offer wide range of vascular interventional and implantable products, including PTCA, NC PTCA, CTO, PTA, inflation device, radial artery tourniquet, diagnostic electrophysiology catheter, cardiac ablation catheter, and vena cava filter.
Do you have certificates for your products?
Our facility is ISO 13485 (medical device quality management system) certified. Some of products have CE marks and FDA approval. Other products are being registered at this moment. Please contact us to check if your demand products can be distributed in your market.
Would you send me free samples?
In most cases, we offer one or two samples for your evaluation. Please advise your express account number to get free samples.
What is your minimum order qty (MOQ)?
There is no MOQ required. One piece is okay to be shipped.
What is the payment terms?
100% T/T payment in advance.
What is the lead time?
It depends on products. Please contact us for details.
Do you provide OEM service?
Yes, please send us your drawings and specifications to make your own brand product.Are
Are your products sterilized?
Yes, all of our products are EO sterilized.
How do you ensure products' quality?
Quality is life. We have conducted raw materials inspection, in progress quality control, finished products and package inspection according to ISO 13485 requirements. QA & QC is deployed throughout all processes. This is to ensure products you receive has zero defect.
Contact information
Pika
Koss Medtech (Suzhou) Co., Ltd.
F3, BLDG 6, No. 8, Jinfeng Road, Suzhou New District, P.R. China
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