Ptca Balloon Dilatation Catheter with FDA Certificate

Product Details
Customization: Available
Feature: Disposable
Certification: CE, FDA, ISO13485
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  • Ptca Balloon Dilatation Catheter with FDA Certificate
  • Ptca Balloon Dilatation Catheter with FDA Certificate
  • Ptca Balloon Dilatation Catheter with FDA Certificate
  • Ptca Balloon Dilatation Catheter with FDA Certificate
  • Ptca Balloon Dilatation Catheter with FDA Certificate
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Basic Info.

Model NO.
ptca
Group
Adult
Type
PCI
Material
Nylon, Pebax
Ethylene Oxide Sterilization
Ethylene Oxide Sterilization
Logo Printing
with Logo Printing
Quality Guarantee Period
Three Years
Nominal Burst Pressure
6 ATM
Rated Burst Pressure
16ATM
Balloon Folding
3
Catheter Lengthcatheter Length
142cm
Transport Package
Box or Pouch
Specification
Diameter from 1.0mm to 5.0mm
Trademark
Kossel, OEM, Global
Origin
Suzhou China
HS Code
9018390000
Production Capacity
5000PCS/Month

Product Description

Company Profile

Ptca Balloon Dilatation Catheter with FDA CertificatePtca Balloon Dilatation Catheter with FDA Certificate

Kossel Medtech (Suzhou) Co., Ltd was founded in 2013, specializing in coronary,peripheral intervention medical devices, electrophysiology series products and other related accessories. We also welcome OEM/ODM cooperation.

Our initial team members are experienced field experts from China and The USA. Our current core teams have more than 10 years of experience in the field and our total staff number exceeds 200 people.

With consistent innovation abilities, advanced production capacity and 7,000 square meters of professional facilities and laboratories; we have obtained more than 100 intellectual property rights or patents, passed ISO 9001, ISO 13485 and GMP systems. We were awarded CE, FDA, KFDA and PMDA certificates, and earned the honorary titles of a "Unicorn" and "Gazelle" company. We have also undertaken the commercialization projects of scientific and technological achievements from our government. Our products are used in dozens of countries and we have customers on every continent.

We devote ourselves to developing excellent products, strive to be an international leading enterprise in the intervention field and are fully committed to contributing to human well-being! 



Feature
Ptca Balloon Dilatation Catheter with FDA Certificate
1. Laser forming technology allows for a small and soft tip resulting in a smooth passing of stenosis
2. The patented hydrophilic coating is lubricated resulting in a good delivery performance and reducing 80% of friction
3. Laser bonding technology connects the balloon and catheter well, helping get through tortuous vessel
4. The balloon has a small profile through a 3-wing folding process which smooths the crossing of stenosis, reduces damage and allows for easier recovering
5. A tapered tip and core wire allow for excellent delivery performance

Ptca Balloon Dilatation Catheter with FDA Certificate


Balloon Compliance and Rated Burst Pressure

            P/atm D/mm            Tolerance of Compliance:±5%
6 (NP) 8 10 12 14 16 (RBP) 18
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
2.5 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
3.5 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 35 40
1.5 - - -
2.0 - -
2.5
2.75
3.0
3.5
4.0


CE ISO Certificate

Ptca Balloon Dilatation Catheter with FDA CertificatePtca Balloon Dilatation Catheter with FDA CertificatePtca Balloon Dilatation Catheter with FDA CertificatePtca Balloon Dilatation Catheter with FDA Certificate

Production Line

Ptca Balloon Dilatation Catheter with FDA CertificatePtca Balloon Dilatation Catheter with FDA CertificatePtca Balloon Dilatation Catheter with FDA CertificatePtca Balloon Dilatation Catheter with FDA Certificate
 

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