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510(k) K982385

POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER by Porous Media Corp. — Product Code KRJ

K982385 is an FDA 510(k) premarket notification submitted by Porous Media Corp. for the device "POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER". The FDA issued a decision of Substantially Equivalent on February 1, 1999. The device falls under product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4280. Porous Media Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1999
Date Received
July 9, 1998
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 Porous Media Corp.

  • K062091 — POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION (August 8, 2006)
  • K061426 — OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 (June 5, 2006)
  • K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (October 1, 1999)
  • K982127 — POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER (June 23, 1998)
  • K965020 — POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER (March 14, 1997)
  • K964979 — POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER (March 11, 1997)
  • K952428 — POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER (July 7, 1995)
  • K934132 — POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER (October 4, 1994)

Other clearances for product code KRJ

  • K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (October 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)
  • K861226 — INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 (June 2, 1986)

FDA data resources