510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201068Substantially Equivalent

Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface

Medtronic, Inc., Minneapolis MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K201068 is the FDA 510(k) clearance record for Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface, a class II device, cleared for Medtronic, Inc. on under FDA product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K201068.

Clearance record

Decision date
Received
(29 days to decision)
Product code
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation
21 CFR 870.4360
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic, Inc. 7611 Northland Dr., Minneapolis MN
510(k) summary
Statement
Third party review
No

Clearances, product code KFM

Trailing 12 months

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

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