FDA product code PQK

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Cardiovascular·Class 2·21 CFR 870.1252
US regulatory classifications
US Product Code (FDA)
PQK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.1252
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.

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About this record

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.