510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901628Substantially Equivalent

Applied Vascular Devices 6Mm Traction Clip

Applied Vascular Devices, Inc., Laguna Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901628 is the FDA 510(k) clearance record for APPLIED VASCULAR DEVICES 6MM TRACTION CLIP, a class II device, cleared for Applied Vascular Devices, Inc. on under FDA product code DXC (Clamp, Vascular). FDA records list 21 510(k) clearances for Applied Vascular Devices, Inc., from to . As of , FDA records show no recalls naming K901628.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Applied Vascular Devices, Inc. 26051 Merit Cir., #104, Laguna Hills CA
Third party review
No

Clearances, product code DXC

Trailing 12 months
6 clearances under product code DXC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260