510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K203111Substantially Equivalent

Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System

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

K203111 is the FDA 510(k) clearance record for Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System, a class II device, cleared for Medtronic on under FDA product code DTZ (Oxygenator, Cardiopulmonary Bypass). FDA records list 1,525 510(k) clearances for Medtronic, from to . As of , FDA records show 6 recalls naming K203111.

Clearance record

Decision date
Received
(336 days to decision)
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
Regulation
21 CFR 870.4350
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic 7611 Northland Dr., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTZ

Trailing 12 months
5 clearances under product code DTZ in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DTZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260