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Venous Window Needle Guide

FDA product code PFH · 1 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5540
Review panel
GU
Implant
Yes
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2013-09-13 – 2013-09-13

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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