510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PFHClass II

Venous Window Needle Guide

21 CFR 876.5540 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PFH is the FDA product code for Venous Window Needle Guide, a class II device type, regulated under 21 CFR 876.5540. FDA's definition for this code reads: "For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PFH
Device name
Venous Window Needle Guide
FDA 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.
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PFH

By decision year
1 clearance under product code PFH with a decision year between 2013 and 2013, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PFH by decision year
YearClearances
20131

Applicants with the most clearances

Product code PFH
Applicants holding the most 510(k) clearances under product code PFH
ApplicantClearances
Vital Access1

Companies listing this code with FDA

Companies whose registered establishments list this code