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510(k) K964571

VISION CARDIOPLEGIA DELIVERY SYSTEM by Lifestream Int'L, Inc. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1997
Date Received
November 14, 1996
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 Lifestream Int'L, Inc.

  • K962354 — DIOMED 15, 30, 60 SURGICAL DIODE LASER (September 11, 1996)
  • K920178 — CARDIOTOMY RESERVOIR W/20 MICRON FILITER (May 13, 1993)
  • K920618 — AUTOTRANSFUSION SUCTION SET (March 12, 1993)
  • K913181 — AUTOLOGOUS BLOOD PROCESSING SYSTEM (May 20, 1992)
  • K914396 — SURGI LIGHT NON-CONTACT FIBERS (December 23, 1991)
  • K912045 — TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST (October 31, 1991)
  • K911523 — MODIFICATION TO MODEL 90-1460 LASER ADAPTER (April 22, 1991)
  • K910726 — LIGHT-TOUCH AND SURGI LIGHT FIBERS (March 29, 1991)
  • K904491 — TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 (February 1, 1991)
  • K903709 — SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH (October 26, 1990)

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  • 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)