FDA product code PFH

Venous Window Needle Guide

Gastroenterology, Urology·Class 2·21 CFR 876.5540·Implantable·Life-sustaining
US regulatory classifications
US Product Code (FDA)
PFH
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.5540
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
Yes
Third party review
Not Eligible
Definition

For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion.

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About this record

Venous Window Needle Guide is a medical device type in the Gastroenterology, Urology 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. This device type includes implantable products. This device type includes life-sustaining products.

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.