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510(k) K925369

BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS by Sorin Biomedica, Fiat, USA, Inc. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1993
Date Received
October 23, 1992
Clearance Type
Traditional
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 Sorin Biomedica, Fiat, USA, Inc.

  • K931444 — PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS (May 27, 1994)
  • K925661 — STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE (May 18, 1993)
  • K925615 — SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE (March 26, 1993)
  • K924354 — STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (February 18, 1993)
  • K925541 — STOCKERT 1/4 BUBBLE SENSOR (February 2, 1993)
  • K922933 — SORIN MONOLYRH INTEGRATED MEMBRANE LUNG (November 30, 1992)
  • K854963 — S80 IMPLANTABLE CARDIAC PACING LEAD (June 24, 1986)
  • K852641 — ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER (January 14, 1986)
  • K851365 — SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM (December 3, 1985)
  • K841947 — ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT (June 25, 1984)

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  • 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)