FDA Approved Disposable Ptca Balloon Dilatation Catheter

• Type：Catheter
• Material：Nylon
• Ethylene Oxide Sterilization：Ethylene Oxide Sterilization
• Quality Guarantee Period：Three Years
• Group：Adult
• Logo Printing：With Logo Printing

=== Base Info ===

• Model NO.：PTCA
• Feature：Disposable
• Certification：CE, FDA, Nmpa,Kfda,Pmda
• Application：Cardiovascular
• Sterilization：Eo
• Nominal Burst Pressure：6 ATM
• Rated Burst Pressure：16 ATM
• Balloon Folding：3
• Catheter Lengthcatheter Length：142cm
• Trade Mark：Selethru
• Country of Origin：Suzhou China
• Manufactuer：Yes
• Rx or Otw：Rx
• Hydrophilic Coating：Yes
• OEM/ODM/Cdmo：Yes
• Factory Certificate：ISO9001, ISO13485
• Transport Package：Box or Pouch
• Specification：Diameter from 1.75mm to 5.0mm
• Trademark：OEM, Global
• Origin：Suzhou China
• HS Code：9018390000
• Production Capacity：5000PCS,Month

=== Description ===

Basic Info.

Model NO. PTCA Feature Disposable Certification CE, FDA, Nmpa,Kfda,Pmda Application Cardiovascular Sterilization Eo Nominal Burst Pressure 6 ATM Rated Burst Pressure 16 ATM Balloon Folding 3 Catheter Lengthcatheter Length 142cm Trade Mark Selethru Country of Origin Suzhou China Manufactuer Yes Rx or Otw Rx Hydrophilic Coating Yes OEM/ODM/Cdmo Yes Factory Certificate ISO9001, ISO13485 Transport Package Box or Pouch Specification Diameter from 1.75mm to 5.0mm Trademark OEM, Global Origin Suzhou China HS Code 9018390000 Production Capacity 5000PCS/Month

Product Description

Company Profile
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!  

Our Mission: Develop superb medical devices for people's health and benefits.
Our Vision: Innovation for systematic clinical solutions, and a world-wide intervention leader.
Our Values: Be Pragmatic, Efficient, Collaborative, Willing to share, Hardworking and Dedication.

Product Features:



1. Material has excellent resistance to high pressure, NP-12atm and RBP-22atm, to provide good dilation performance in calcified lesions
2. Low compliance design and low inflation rate from NP to RBP supply accurate concentrations of expansion size and optimizing expansion effect
3. A short taper shoulder reduces the excess expansion at balloon ends, allows for a better focus on the target lesion and minimizes the damages to the vessel
4. A super slippery hydrophilic coating improves the catheter's ability to push forward and decreases operation time
5. Brilliant performance of folding after balloon expansion allowing for easier withdrawal

Size Matrix

L:mm D:mm

6

8

9

10

12(NP)

14

15

16

18

20

22(RBP)

24

25

26

27

30

1.75

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2.00

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2.25

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2.50

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2.75

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3.25

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3.50

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3.75

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4.00

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4.50

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5.00

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Production Line



Certificate

1.What products do you offer?
We offer wide range of vascular interventional and implantable products, including PTCA, NC PTCA, CTO, PTA/HP PTA balloon catheter, inflation device, radial artery tourniquet, diagnostic electrophysiology catheter, cardiac ablation catheter, vena cava filter and stent/stent system.
OEM/ODM service is also covered. 

2.What certificates do you obtain?
ISO 9001, ISO 13485, GMP, CE, FDA, KFDA, PMDA and NMPA certificates

3. What is your minimum order quantity (MOQ)?
30pcs

4.Are your products sterilized?
Yes, all of our products are EO sterilized.

5.I'm a distributor and I need validate your products prior to distributing in my region. Would you send me free samples?
In most cases, we offer one or two samples for evaluation. Express fee will be paid by clients. 

6.I am looking for components, such as plastic tubes, connectors. Can you offer me these?
Yes, we can provide components or raw materials.

7.What is your payment term?
EXW quotation, 100% T/T payment in advance.

8.How many countries are your products used? 
More than 30, we have customers on every continent