510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895214Substantially Equivalent

Hemostasis Valve

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

K895214 is the FDA 510(k) clearance record for HEMOSTASIS VALVE, a class II device, cleared for Applied Vascular Devices, Inc. on under FDA product code DYB (Introducer, Catheter). FDA records list 21 510(k) clearances for Applied Vascular Devices, Inc., from to . As of , FDA records show no recalls naming K895214.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
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 DYB

Trailing 12 months
18 clearances under product code DYB in the twelve months to October 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20260