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510(k) K832396

CENTRAL VENOUS ACCESS CATHETER CVAC by Gish Biomedical, Inc. — Product Code DOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1983
Date Received
July 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Gish Biomedical, Inc.

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  • K091062 — MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 (August 4, 2009)
  • K083131 — MEDOS HILITE RESERVOIR, MODEL: 4030 (July 30, 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)

Other clearances for product code DOY

  • K910154 — USCI ILLUMEN-8 8F PTCA GUIDING CATHETER (April 9, 1991)
  • K831239 — WALRUS PERCUTANEOUS INTRODUCER SET (May 25, 1983)
  • K831191 — VASCULAR CATHETER (May 9, 1983)
  • K831188 — CONNECTOR TUBE (May 9, 1983)