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510(k) K920178

CARDIOTOMY RESERVOIR W/20 MICRON FILITER by Lifestream Int'L, Inc. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1993
Date Received
January 14, 1992
Clearance Type
Traditional
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 Lifestream Int'L, Inc.

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  • K962354 — DIOMED 15, 30, 60 SURGICAL DIODE LASER (September 11, 1996)
  • 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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