PFH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Venous Window Needle Guide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Medical specialty
- Gastroenterology, Urology
- Flags
- Implant · Life-sustaining
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M (K130873) | Vital Access | 2013-09-13 |
Track PFH automatically
Every clearance here is in the API, with alerts when new ones post.