510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K860497Substantially Equivalent

Carotid Balloon Shunt

Imodex, Inc., St. Clair Shores MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860497 is the FDA 510(k) clearance record for CAROTID BALLOON SHUNT, a class II device, cleared for Imodex, Inc. on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 2 510(k) clearances for Imodex, Inc., from to . As of , FDA records show no recalls naming K860497.

Clearance record

Decision date
Received
(107 days to decision)
Product code
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation
21 CFR 870.4210
Device class
Class II
Review panel
Cardiovascular
Applicant
Imodex, Inc. 29001 Harper Ave. Suite 5, St. Clair Shores MI
Third party review
No

Clearances, product code DWF

Trailing 12 months
8 clearances under product code DWF in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20262
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261