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510(k) K803101

PREBYPASS FILTER CAT.#K-5 by Delta Medical Industries — Product Code KRJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1980
Date Received
December 9, 1980
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

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  • K820912 — PMS-2 PRESSURE MONITOR SEPARATOR (May 18, 1982)
  • K820482 — ACCU-RYNGE INSULIN PUMP #SP-250 (March 26, 1982)
  • K810068 — PEDIATRIC ARTERIAL BLOOD FILTER (January 22, 1981)
  • K802755 — ARTERIAL BLOOD FILTER BF-37 (January 7, 1981)

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  • 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)