Home / 510(k) Clearances / K832594

510(k) K832594

PRE-BYPASS FILTER #EC-PBF SERIES by Gish Biomedical, Inc. — Product Code KRJ

K832594 is an FDA 510(k) premarket notification submitted by Gish Biomedical, Inc. for the device "PRE-BYPASS FILTER #EC-PBF SERIES". The FDA issued a decision of Substantially Equivalent on September 20, 1983. The device falls under product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4280. Gish Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1983
Date Received
August 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Prebypass, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4280
Review Panel
CV
Submission Type

Other clearances by Gish Biomedical, Inc.

  • K090449 — MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT (September 18, 2009)
  • K090450 — MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT (September 18, 2009)
  • 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 KRJ

  • K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (October 1, 1999)
  • K982385 — POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER (February 1, 1999)
  • K940126 — AVECOR PRE-BYPASS FILTER (June 28, 1994)
  • K900672 — PREBYPASS FILTER, CAT. NO. FPB-5 (April 3, 1990)
  • K885154 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM (February 22, 1989)
  • K884390 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER (December 21, 1988)
  • K884244 — INTERSEPT* PREBYPASS FILTER (December 5, 1988)
  • K883086 — INTERSEPT*PREBYPASS FILTER (September 16, 1988)
  • K875094 — ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K871350 — PREBYPASS FILTER (June 8, 1987)

FDA data resources