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510(k) K131666

ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING by Maquet Cardiopulmonary, AG — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2013
Date Received
June 7, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
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)
  • K130300 — HEATER-COOLER UNIT HCU 40 (July 1, 2013)
  • K123288 — HEMOCONCENTRATOR (June 26, 2013)
  • K130639 — ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX (May 16, 2013)

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  • K253671 — Dual Stage Venous Cannulae (January 30, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K253106 — AngioVac Cannula (October 24, 2025)
  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)
  • K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (June 27, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (May 31, 2024)