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510(k) K913181

AUTOLOGOUS BLOOD PROCESSING SYSTEM by Lifestream Int'L, Inc. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1992
Date Received
July 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
Review Panel
CV
Submission Type

Other clearances by Lifestream Int'L, Inc.

  • K964571 — VISION CARDIOPLEGIA DELIVERY SYSTEM (August 8, 1997)
  • 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)
  • 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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  • K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc (September 3, 2021)
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  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)