510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901627Substantially Equivalent

Arterial Embolectomy Catheter

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

K901627 is the FDA 510(k) clearance record for ARTERIAL EMBOLECTOMY CATHETER, a class II device, cleared for Applied Vascular Devices, Inc. on under FDA product code DXE (Catheter, Embolectomy). FDA records list 21 510(k) clearances for Applied Vascular Devices, Inc., from to . As of , FDA records show one recall naming K901627.

Clearance record

Decision date
Received
(193 days to decision)
Product code
DXE Catheter, Embolectomy
Regulation
21 CFR 870.5150
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 DXE

Trailing 12 months

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

FDA records show no clearances under product code DXE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXE, 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