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510(k) K083131

MEDOS HILITE RESERVOIR, MODEL: 4030 by Gish Biomedical, Inc. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2009
Date Received
October 23, 2008
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 Gish Biomedical, Inc.

  • K090450 — MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT (September 18, 2009)
  • K090449 — MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT (September 18, 2009)
  • K091062 — MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 (August 4, 2009)
  • K082403 — MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT (May 15, 2009)
  • K081947 — GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING (February 4, 2009)
  • K082082 — GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING (February 4, 2009)
  • K080708 — VISION HOLLOW FIBER OXYGENATOR WITH HA COATING (February 2, 2009)
  • K081838 — GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING (January 26, 2009)
  • K081881 — GISH TUBING AND CONNECTORS WITH HA COATING (January 23, 2009)
  • K081054 — GISH ARTERIAL FILTER WITH HA COATING (January 15, 2009)

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