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510(k) K875094

ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE by Pall Biomedical Products Co. — Product Code KRJ

K875094 is an FDA 510(k) premarket notification submitted by Pall Biomedical Products Co. for the device "ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE". The FDA issued a decision of Substantially Equivalent on February 29, 1988. The device falls under product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4280. Pall Biomedical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 1988
Date Received
December 10, 1987
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 Pall Biomedical Products Co.

  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K960993 — PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) (April 22, 1996)
  • K905794 — PALL 3N1 FILTER (June 13, 1991)
  • K902518 — LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE (October 16, 1990)
  • K884534 — PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER (January 24, 1989)
  • K875095 — PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K873666 — PALL LEUKOCYTE REMOVAL FILTER, BLOOD (January 6, 1988)
  • K873667 — PALL LEUKOCYTE REMOVAL FILTER, PLATELETS (January 6, 1988)
  • K874405 — PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE (December 30, 1987)
  • K853987 — PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE (December 11, 1985)

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)
  • K871350 — PREBYPASS FILTER (June 8, 1987)
  • K861226 — INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 (June 2, 1986)

FDA data resources