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510(k) K090690

VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING by Maquet Cardiopulmonary, AG — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2009
Date Received
March 16, 2009
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 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)

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  • 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)
  • K141233 — AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSU (June 12, 2014)