510(K) CLEARANCES 63 ▲12RECALLS POSTED 17 ▼8CLASS I 1PMA DECISIONS 48 ▼2WEEK ENDING / FDA DATA AS OF
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K991066Substantially Equivalent

Madtronic Dlp Arterial Cannulae

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

K991066 is the FDA 510(k) clearance record for MADTRONIC DLP ARTERIAL CANNULAE, a class II device, cleared for Medtronic Vascular on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K991066.

Clearance record

Decision date
Received
(167 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 Vascular 620 Watson SW, Grand Rapids MI
510(k) summary
Summary
Third party review
No

Clearances, product code DWF

Trailing 12 months
10 clearances under product code DWF in the twelve months to November 2026, October 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DWF, trailing twelve months
MonthClearances
December 20250
January 20262
February 20262
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20263
November 20260