ClearanceBrief
Panels › Cardiovascular › Product code DTM · Class 2

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Regulation 870.4260

1510(k)s in 12 months (96 all time)
0recalls in 12 months (5 all time)
3recalls that name a 510(k)
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Top companies in DTM

Decided510(k)Device and applicantCode
Mar 18, 1993K920594SHILEY PERFUSION TUBING SETS
Shiley, Inc.
DTM
May 16, 1991K910935MODIFIED PYROGEN TESTING
Electromedics, Inc.
DTM
Dec 13, 1990K902723ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
Electromedics, Inc.
DTM
Oct 16, 1990K902518LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE
Pall Biomedical Products Co.
DTM
May 17, 1990K900758HEPARINIZED ARTERIAL SCREEN BLOOD FILTER
Cobe Laboratories, Inc.
DTM
Jun 22, 1989K892387MODIFIED GELMAN ARTERIAL FILTER
Gelman Sciences, Inc.
DTM
Aug 12, 1988K882137EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40
Medtronic Blood Systems, Inc.
DTM
Jul 14, 1988K873316BUBBLE TRAP-FILTER CAT. NO B180F37
American Omni Medical, Inc.
DTM
May 6, 1988K880671MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER
Medtronic Blood Systems, Inc.
DTM
Feb 29, 1988K875080AIR VENT LINE CAT. NO. AVL-36
American Omni Medical, Inc.
DTM
Jan 2, 1987K864262ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
Johnson & Johnson Professionals, Inc.
DTM
Sep 4, 1986K862609INTERFACE ARTERIAL BLOOD FILTER, MODEL 44
Medical, Inc.
DTM
Sep 4, 1986K862591INTERFACE ARTERIAL BLOOD FILTER, MODEL 42
Medical, Inc.
DTM
Aug 8, 1986K862068GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)
Gelman Sciences, Inc.
DTM
Feb 26, 1986K855066SWANK ARTERIAL LINE BLOOD FILTER HF6000
Cobe Laboratories, Inc.
DTM
Dec 11, 1985K853987PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE
Pall Biomedical Products Co.
DTM
Jul 29, 1985K851003ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX
Gish Biomedical, Inc.
DTM
Jan 8, 1985K842813HEPARIN COATED ARTERIAL BLOOD FILTERS
American Bentley
DTM
Aug 3, 1984K834382PALL EC PLUS FILTER W/FILTER SLEEVE
Pall Biomedical Products Co.
DTM
Aug 3, 1984K834380PALL EC PLUS FILTER
Pall Biomedical Products Co.
DTM
Apr 17, 1984K840612PEDIATRIC ARTERIAL BLOOD FILTER
American Bentley
DTM
Dec 29, 1983K831507LOW TRAUMA ARTERIAL FILTER H-640
C.R. Bard, Inc.
DTM
Dec 27, 1983K833477INTERSEPT 40 MICRON FILTER
Extracorporeal Medical Specialities, Inc.
DTM
Dec 27, 1983K833476INTERSEPT 40 MICRON FILTER W/TUBING
Extracorporeal Medical Specialities, Inc.
DTM
Oct 20, 1983K833048PURGES LINES, PL-45 & PL-33
American Bentley
DTM
Jan 28, 1983K830132ARTERIAL BLOOD FILTER AF-1040-AF-1040BL
American Bentley
DTM
Jan 28, 1983K830131ARTERIAL BLOOD FILTER AF-1025-AF-1025BL
American Bentley
DTM
Nov 30, 1982K823108INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT
Extracorporeal Medical Specialities, Inc.
DTM
Nov 24, 1982K823258INTERFACE ARTERIAL BLOOD FILTER #40
Medical, Inc.
DTM
Jun 29, 1982K820044ARTERIAL BLOOD FILTER, #AF-1025
Bentley Laboratories, Inc.
DTM
Jun 17, 1982K820679PEDIATRIC ARTERIAL BLOOD FILTER #AF-540
Bentley Laboratories, Inc.
DTM
Jun 17, 1982K820343ARTERIAL BLOOD FILTER MODEL #AF-1040
Bentley Laboratories, Inc.
DTM
Mar 15, 1982K820472WILLIAM HARVEY H-625 ARTERIAL FILTER
C.R. Bard, Inc.
DTM
Jan 29, 1982K820045CARDIOVASCULAR DEVICES
Bentley Laboratories, Inc.
DTM
Dec 14, 1981K812659TERUMO HOLLOW OXYGENATOR CIRCUIT
Terumo Medical Corp.
DTM
Nov 27, 1981K813131INTERFACE ARTERIAL BLOOD FILTER
Medical, Inc.
DTM
Nov 2, 1981K812742SHILEY ARTERIAL FILTER W/40 MICRON SCREE
Shiley, Inc.
DTM
Jun 9, 1981K811379SHILEY ARTERIAL FILTER
Shiley, Inc.
DTM
Jan 22, 1981K810068PEDIATRIC ARTERIAL BLOOD FILTER
Delta Medical Industries
DTM
Jan 7, 1981K802755ARTERIAL BLOOD FILTER BF-37
Delta Medical Industries
DTM
Nov 12, 1980K802602L-3 PURGE LINE
Delta Medical Industries
DTM
Jun 4, 1980K801147PEDIATRIC ARTERIAL BLOOD FILTER #AF-5
Bentley Laboratories, Inc.
DTM
Dec 19, 1979K792450ARTERIAL BLOOD FILTER, MODEL AF-10
Bentley Laboratories, Inc.
DTM
Oct 2, 1979K791748ULTIPOR BLOOD FILTER EXTRA-CORPOREAL
Pall Biomedical Products Co.
DTM
Mar 27, 1979K790435INTERSEPT* BLOOD FILTER W/ TUBING BYPASS
Surgikos, Inc.
DTM
Oct 26, 1978K781707FILTER, ARTERIAL BLOOD W/TUBING BYPASS
Surgikos, Inc.
DTM

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