510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K130873Substantially Equivalent

Vwing Vascular Needle Guide, 4Mm X 07Mm; Vwing Vascular Needle Guide, 6Mm X 07Mm; Vwing Vascular Needle Guide, 8Mm X 07M

Vital Access, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130873 is the FDA 510(k) clearance record for VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M, a class II device, cleared for Vital Access on under FDA product code PFH (Venous Window Needle Guide). FDA's definition for product code PFH 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". FDA records list one 510(k) clearance for Vital Access. As of , FDA records show no recalls naming K130873.

Clearance record

Decision date
Received
(168 days to decision)
Product code
PFH Venous Window Needle Guide
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vital Access 2302 S.Presidents Dr., Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFH

Trailing 12 months

FDA records hold no clearances under product code PFH in the trailing twelve months.

FDA records show no clearances under product code PFH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260