Home / 510(k) Clearances / K141233

510(k) K141233

AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE by Medtronic, Inc. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2014
Date Received
May 13, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

Other clearances by Medtronic, Inc.

  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (February 19, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K251744 — Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Ar (January 16, 2026)
  • K251831 — Bio-Medicus Life Support Catheter and Introducer (January 15, 2026)
  • K253511 — Concerto Versa™ Detachable Coil (January 14, 2026)
  • K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320 (December 19, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K250075 — Medtronic Stedi Extra Support Guidewire (June 13, 2025)
  • K250199 — VitalFlow Console (May 20, 2025)
  • K250558 — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) (March 27, 2025)

Other clearances for product code DTN

  • K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs (December 22, 2025)
  • K241206 — Quantum Perfusion Hybrid System (July 18, 2024)
  • K241053 — MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous (May 15, 2024)
  • K223361 — BMR 1900 PHISIO (June 10, 2023)
  • K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (March 17, 2017)
  • K161733 — INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (March 8, 2017)
  • K153143 — Capiox Advance Hardshell Reservoir (December 2, 2015)
  • K151110 — Intersept Filtered Cardiotomy Reservoir (May 27, 2015)
  • K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDI (July 7, 2014)
  • K140321 — INITARY BETTER BLADDER-PEDIATRIC (April 17, 2014)