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High Pressure PTCA Balloon Catheter for Cardiovascular Interventions with CE/FDA Certification High Pressure PTCA Balloon Catheter for Cardiovascular Interventions with CE/FDA Certification
High Pressure PTCA Balloon Catheter for Cardiovascular Interventions with CE/FDA Certification High Pressure PTCA Balloon Catheter for Cardiovascular Interventions with CE/FDA Certification
High Pressure PTCA Balloon Catheter for Cardiovascular Interventions with CE/FDA Certification High Pressure PTCA Balloon Catheter for Cardiovascular Interventions with CE/FDA Certification

High Pressure PTCA Balloon Catheter for Cardiovascular Interventions with CE/FDA Certification

US$ 35.50 ~ 55.50
Min.Order: 500
Product origin: Suzhou, Jiangsu, China
Category: Toys
Product Name: Toys
Availability:In Stock
Product Review : 128 Reviews
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* Please contact the supplier via whatsapp first before placing an order
  • Model Number : KPTCA
  • Product Type : PTCA Balloon Catheter
  • Material : Medical Grade Pebax
  • Sterilization Method : Ethylene Oxide
  • Quality Guarantee : 3 Years
  • Certifications : CE, FDA, NMPA, KFDA, PMDA
  • Application : Cardiovascular Interventions
  • Tip Profile : 0.016 inch
  • Nominal Pressure : 12 ATM
  • Rated Burst Pressure : 22 ATM
  • Catheter Length : 142 cm
  • Hydrophilic Coating : Yes
  • Diameter Range : 1.75-5.0 mm
  • Length Options : 6-30 mm
  • Compliance : Low Compliance Design
  • OEM/ODM Service : Available
  • Production Standards : ISO 9001, ISO 13485

We're currently running a batch of 500 units for another client, so lead time on yours would be roughly 25 working days from PO (usually 2-4 weeks, but we'll confirm). The KPTCA catheter's rated burst pressure hits 22 ATM, which is better than most for calcified lesions—nominal is 12 ATM, and that low compliance design keeps you from over-expanding. 2. Basically, the balloon folds into three wings and the tip profile is 0.016 inch, so it tracks pretty well through tight spots—we've had feedback from a few interventional cardiologists who say it's smoother than some competing designs. 3. One thing though: it's not ideal for very tortuous vessels below 2.0 mm, because the 142 cm catheter length can feel a bit stiff in those cases, though the hydrophilic coating does help pushability. 4. Diameter options run from 1.75 to 5.0 mm, and lengths from 6 to 30 mm—OEM packaing is available if you need custom labeling, but MOQ is typically 200 units or so. 5. And certifictes cover CE, FDA, NMPA, KFDA, and PMDA, so compliance won't be a headache for most markets—the 3-year qualiy guarantee is standard. 6. Anyway, we'll ship via DDP if you want door-to-door, or FOB Shenzhen—just let us know the specs mix and we'll price it per lot.

PTCA Balloon Catheter Packaging

Frequently Asked Questions

What is the minimum order quantity for the KPTCA balloon catheter?

MOQ is typically 100 pieces for standard sizes, but we can discuss lower quantities for first-time orders or specific custom requests.

What is the typical lead time for OEM/ODM orders?

Standard production takes 3-4 weeks, but custom labeling or packaging can add 1-2 weeks depending on complexity.

Can you provide the CE and FDA certification documents before purchase?

Yes, we can share copies of our CE, FDA, NMPA, KFDA, and PMDA certificates under a mutual NDA for verification.

What is the catheter length and is it fixed at 142 cm?

The standard catheter length is 142 cm, but we offer customization for shorter or longer lengths if needed for specific procedures.

How should these balloon catheters be stored after sterilization?

Store them in a cool, dry place away from direct sunlight, ideally between 15-30°C, and keep them in their original sterile packaging until use.

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