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510(k) K012898

MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM by Cobe Cardiovascular, Inc. — Product Code DTR

K012898 is an FDA 510(k) premarket notification submitted by Cobe Cardiovascular, Inc. for the device "MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM". The FDA issued a decision of Substantially Equivalent on September 17, 2001. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Cobe Cardiovascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2001
Date Received
August 29, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat-Exchanger, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4240
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)
  • K033641 — SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 (December 11, 2003)
  • 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)

Other clearances for product code DTR

  • K252541 — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (March 12, 2026)
  • K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery (July 8, 2025)
  • K250150 — VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGU (May 30, 2025)
  • K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOther (February 23, 2024)
  • K223879 — Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) (April 13, 2023)
  • K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat (May 6, 2022)
  • K212688 — Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exc (January 10, 2022)
  • K201984 — MPS 3 ND Myocardial Protection System (November 20, 2020)
  • K200438 — MPS 3 Myocardial Protection System (June 19, 2020)
  • K173716 — MPS2 Myocardial Protection System Console (October 1, 2018)

FDA data resources