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510(k) K812539

PRE-BYPASS FILTER by Gelman Sciences, Inc. — Product Code KRJ

K812539 is an FDA 510(k) premarket notification submitted by Gelman Sciences, Inc. for the device "PRE-BYPASS FILTER". The FDA issued a decision of Substantially Equivalent on October 13, 1981. The device falls under product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4280. Gelman Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1981
Date Received
September 3, 1981
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 Gelman Sciences, Inc.

  • K946190 — DRUG DISPENSING SPIKE (March 17, 1995)
  • K943127 — PHARMASSURE LARGE VOLUME TRANSFER FILTERS (September 29, 1994)
  • K941589 — SYRINGE FILTER DEVICES (September 6, 1994)
  • K941020 — DRUG RECONSTITUTION FILTER DEVICE (August 10, 1994)
  • K942275 — VIAL VENT FILTER (July 26, 1994)
  • K941032 — UNKNOWN (May 27, 1994)
  • K910821 — TRANSDUCER PROTECTOR (August 12, 1991)
  • K892387 — MODIFIED GELMAN ARTERIAL FILTER (June 22, 1989)
  • K884176 — CHROMATOGRAPHY KIT (April 4, 1989)
  • K884177 — DRUG STANDARD SET (February 17, 1989)

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