Home / 510(k) Clearances / K101153

510(k) K101153

QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD by Maquet Cardiopulmonary, AG — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2010
Date Received
April 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

Other clearances by Maquet Cardiopulmonary, AG

  • K150267 — QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators (May 7, 2015)
  • K140569 — ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) (November 19, 2014)
  • K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDI (July 7, 2014)
  • K133598 — CARDIOHELP SYSTEM (May 21, 2014)
  • K133265 — QUADROX-IR ADULT AND SMALL ADULT (November 12, 2013)
  • K132166 — VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH (October 30, 2013)
  • K132829 — QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS (October 8, 2013)
  • K131666 — ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE CO (July 5, 2013)
  • K130300 — HEATER-COOLER UNIT HCU 40 (July 1, 2013)
  • K123288 — HEMOCONCENTRATOR (June 26, 2013)

Other clearances for product code DTZ

  • K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Bl (March 12, 2026)
  • K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (December 12, 2025)
  • K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) (November 24, 2025)
  • K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator V (September 12, 2024)
  • K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac (July 10, 2024)
  • K241352 — Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity (June 12, 2024)
  • K231652 — D100 KIDS; D101 KIDS (November 16, 2023)
  • K231773 — Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quant (November 8, 2023)
  • K231414 — CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (November 1, 2023)
  • K230640 — Affinity Fusion™ Oxygenator System (April 6, 2023)