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510(k) K033641

SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 by Cobe Cardiovascular, Inc. — Product Code DTN

K033641 is an FDA 510(k) premarket notification submitted by Cobe Cardiovascular, Inc. for the device "SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800". The FDA issued a decision of Substantially Equivalent on December 11, 2003. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Cobe Cardiovascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2003
Date Received
November 20, 2003
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 Cobe Cardiovascular, Inc.

  • K050111 — SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG (March 8, 2005)
  • K042473 — COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (November 19, 2004)
  • K040184 — DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER (February 26, 2004)
  • K030462 — COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 (March 6, 2003)
  • K021830 — SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM (July 2, 2002)
  • K011835 — COBE REVOLUTION (February 12, 2002)
  • K013480 — COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR (November 16, 2001)
  • K012763 — SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM (November 15, 2001)
  • K001509 — STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE (October 26, 2001)
  • K012898 — MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM (September 17, 2001)

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

FDA data resources