FDA product code PFH: Venous Window Needle Guide
PFH is the FDA product code for venous window needle guide. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under PFH. The average 510(k) review took 168 days (median 168).
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.
Classification
| Field | Value |
|---|---|
| Device name | Venous Window Needle Guide |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every PFH clearance
Top PFH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vital Access | 1 | 2013-09-13 |
Most recent PFH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130873 | Vital Access | VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M | 2013-09-13 | 168 |
Recalls for PFH devices
openFDA lists no recalls for product code PFH.
Frequently asked questions
What is FDA product code PFH?
PFH is the FDA product code for venous window needle guide. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is PFH?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code PFH?
Across 1 cleared submissions the average was 168 days from receipt to decision (median 168).
Which companies have the most PFH clearances?
Vital Access (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PFH
- Run a recall and safety report across every PFH manufacturer
- Watch product code PFH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times