510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101186Substantially Equivalent

Affinity Vard Sub-Assembly for Cps (Carmeda Coated), Purgeline (Uncoated), Holding Bag

Medtronic Perfusion Systems, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101186 is the FDA 510(k) clearance record for AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG, a class II device, cleared for Medtronic Perfusion Systems on under FDA product code DTP (Defoamer, Cardiopulmonary Bypass). FDA records list 29 510(k) clearances for Medtronic Perfusion Systems, from to . As of , FDA records show no recalls naming K101186.

Clearance record

Decision date
Received
(128 days to decision)
Product code
DTP Defoamer, Cardiopulmonary Bypass
Regulation
21 CFR 870.4230
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Perfusion Systems 7611 Northland Dr., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTP

Trailing 12 months

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

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