510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K994171Substantially Equivalent

Medtronic Aortocoronary Shunt and Separately Packaged Arteriotomy Cannulae

Medtronic Cardiac Surgical Products, Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994171 is the FDA 510(k) clearance record for MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE, a class II device, cleared for Medtronic Cardiac Surgical Products on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 7 510(k) clearances for Medtronic Cardiac Surgical Products, from to . As of , FDA records show no recalls naming K994171.

Clearance record

Decision date
Received
(139 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
Medtronic Cardiac Surgical Products 620 Watson SW, Grand Rapids MI
510(k) summary
Summary
Third party review
No

Clearances, product code DWF

Trailing 12 months
6 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 20260
October 20260