510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K172984Substantially Equivalent

Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface

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

K172984 is the FDA 510(k) clearance record for Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface, a class II device, cleared for Medtronic, Inc. on under FDA product code DTZ (Oxygenator, Cardiopulmonary Bypass). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K172984.

Clearance record

Decision date
Received
(54 days to decision)
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
Regulation
21 CFR 870.4350
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic, Inc. 8200 Coral Sea St. N.E, Mounds View 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