510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894681Substantially Equivalent

Revised Labeling for Arterial Embolectomy Catheter

Shiley, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894681 is the FDA 510(k) clearance record for REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER, a class II device, cleared for Shiley, Inc. on under FDA product code DXE (Catheter, Embolectomy). FDA records list 174 510(k) clearances for Shiley, Inc., from to . As of , FDA records show no recalls naming K894681.

Clearance record

Decision date
Received
(79 days to decision)
Product code
DXE Catheter, Embolectomy
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Shiley, Inc. 17600 Gillette Ave., Irvine 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