Sc Ptca Balloon Dilatation Catheter with ISO 13485

• Customization: Available
• Material: Pebax/Nylon
• Application: Cardiovascular
• Model NO.: KPTCA150010 to KPTCA400040
• Group: Adult or Children
• Certification: Ce, ISO13485
• Nominal Burst Pressure: 6 ATM
• Rated Burst Pressure: 16 ATM
• Balloon Folding: 3
• Catheter Lengthcatheter Length: 142cm
• Logo Printing: Both with Logo Printing and Without
• Transport Package: Box or Pouch
• Specification: Diameter from 1.5mm to 4.0mm
• Trademark: Kossel, 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! 


Product Features:



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

 

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	√	√	√	√	√	√	√

Production Line









Certificate







FAQ
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)?
30pc

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