Product code PFH— Gastroenterology, Urology

VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M

Classification name: Venous Window Needle Guide
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Total cleared: 1
First cleared: 2013-09-13
Most recent: 2013-09-13

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code PFH under 21 CFR 876.5540, via openFDA

Market context for product code PFH

FDA has cleared 1 device under product code PFH, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PFH

Vital Access1 clearance

Recent clearances under product code PFH

K130873 — VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07MVital Access·2013-09-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.