Product code PFH
- Device name
- Venous Window Needle Guide
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5540
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- 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.
- Source
- FDA openFDA device classification dataset