Atlas FDA

KRJ

24 FDA 510(k) clearances · Product code

57 daysmedian time to decision
169 days90th percentile
24clearances measured

FDA profile

Official device name
Filter, Prebypass, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4280
Medical specialty
Cardiovascular
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RecordFirmDate
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (K990276)Porous Media Corp.1999-10-01
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER (K982385)Porous Media Corp.1999-02-01
AVECOR PRE-BYPASS FILTER (K940126)Avecor Cardiovascular, Inc.1994-06-28
PREBYPASS FILTER, CAT. NO. FPB-5 (K900672)American Omni Medical, Inc.1990-04-03
INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM (K885154)Medtronic Blood Systems, Inc.1989-02-22
INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER (K884390)Medtronic Blood Systems, Inc.1988-12-21
INTERSEPT* PREBYPASS FILTER (K884244)Medtronic Blood Systems, Inc.1988-12-05
INTERSEPT*PREBYPASS FILTER (K883086)Medtronic Blood Systems, Inc.1988-09-16
ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE (K875094)Pall Biomedical Products Co.1988-02-29
PREBYPASS FILTER (K871350)American Omni Medical, Inc.1987-06-08
INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 (K861226)Medical, Inc.1986-06-02
COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER (K850139)Rapid Diagnostic Laboratories, Inc.1985-04-10
SOLUTION CLARIFICATION UNIT (K842141)Pall Biomedical Products Co.1984-08-03
SHILEY PREBYPASS FILTER (K840450)Shiley, Inc.1984-04-17
PRE-BYPASS FILTER #EC-PBF SERIES (K832594)Gish Biomedical, Inc.1983-09-20
ULTIPORE PREBYPASS PLUS FILTER (K831286)Pall Biomedical Products Co.1983-06-08
PRE-BYPASS FILTER (K812539)Gelman Sciences, Inc.1981-10-13
INTERFACE PRE BYPASS PRIME FILTER #90 (K812244)Medical, Inc.1981-08-25
INTERFACE PRE BYPASS PRIME FILTER (K812240)Medical, Inc.1981-08-25
PRE-BYPASS FILTER (K810395)Texas Medical Products, Inc.1981-03-05
PREBYPASS FILTER CAT.#K-5 (K803101)Delta Medical Industries1980-12-22
CARDIOPLEGIA ADMINISTRATION SYSTEM CAS (K800135)Bentley Laboratories, Inc.1980-02-01
RECIRCULATION FILTER MODEL RF-10 (K790361)Bentley Laboratories, Inc.1979-03-28
PREBYPASS FILTER (K780485)Delta Medical Industries1978-04-05

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Every clearance here is in the API, with alerts when new ones post.