ClearanceBrief
Panels › Cardiovascular › Product code DTL · Class 2

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Regulation 870.4290

0510(k)s in 12 months (137 all time)
5recalls in 12 months (59 all time)
46recalls that name a 510(k)
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Top companies in DTL

Company510(k)sRecalls
LivaNova USA Inc.021
Merit Medical Systems, Inc.94
Medline Industries, Inc.16
Terumo Cardiovascular Systems Corp.43
Cook Inc.06
Dlp, Inc.50
North American Instrument Corp.50
Texas Medical Products, Inc.50
Advance Medical Designs, Inc.40
C.R. Bard, Inc.40
Decided510(k)Device and applicantCode
Feb 3, 1995K945461PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)
Medtronics Interventional Vascular
DTL
Jul 5, 1994K911884ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES
Advance Medical Designs, Inc.
DTL
Mar 23, 1994K933084CHECK VALVE (FITTING)
Merit Medical Systems, Inc.
DTL
Nov 23, 1993K934123STOPCOCK (ONE-PORT MANIFOLD)
Merit Medical Systems, Inc.
DTL
May 17, 1993K922840ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS
Gish Biomedical, Inc.
DTL
Jan 22, 1993K925419PASSAGE HEMOSTASIS VALVE
Merit Medical Systems, Inc.
DTL
Dec 11, 1992K915301ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK
Advance Medical Designs, Inc.
DTL
May 20, 1992K914987HIGH PRESSURE CONNECTING SETS, MODIFICATION
E-Z-Em, Inc.
DTL
Dec 20, 1991K913363CUSTOM TUBING PACKS
Kroy Medical, Inc.
DTL
Nov 5, 1991K912969TORQUE FITTING
Freedom Machine, Inc.
DTL
Oct 21, 1991K913161MERIT MANIFOLD
Merit Medical Systems, Inc.
DTL
Sep 11, 1991K912709MX 339 TWIN HEMOSTATIC Y CONNECTOR
Medex, Inc.
DTL
May 21, 1991K910845ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012
Interventional Therapeutics Corp.
DTL
Nov 1, 1990K902741VASCUMED EZ Y-CONNECTOR
Vascumed Systems
DTL
Aug 15, 1990K900994ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.
Dlp, Inc.
DTL
Jun 26, 1990K900652NAMIC PTCA Y-ADAPTOR
North American Instrument Corp.
DTL
Mar 27, 1990K897196ADVANCE STOPCOCKS ADVANCE MANIFOLDS
Advance Medical Designs, Inc.
DTL
Mar 27, 1990K897137RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING
Research Medical, Inc.
DTL
Mar 19, 1990K897197ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.
Advance Medical Designs, Inc.
DTL
Jan 26, 1990K895795HPD TUBING CONNECTORS
Hpd Medical, Inc.
DTL
Dec 7, 1989K892377RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
Research Medical, Inc.
DTL
Dec 7, 1989K892368RMI CARDIOPLEGIA DELIVERY SETS
Research Medical, Inc.
DTL
Aug 3, 1989K893683SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
3M Company
DTL
Jul 24, 1989K891572ANGIOGRAPHY CUSTOM PACKS
Procedure Packs, Inc.
DTL
Jul 14, 1989K890676DISPOSABLE TRANSDUCER MANIFOLD
L.O.N. Research, Inc.
DTL
Apr 19, 1989K890580LIPID STOPCOCK
North American Instrument Corp.
DTL
Jan 12, 1989K884408NAMIC DUAL BACKCHECK VALVE
North American Instrument Corp.
DTL
Dec 28, 1988K882717PROCEDURE PACKS CONTRAST MEDIA SETS
Procedure Packs, Inc.
DTL
Dec 5, 1988K884200USCI TANDEM ADAPTER
C.R. Bard, Inc.
DTL
Oct 28, 1988K883956BIO-MEDICUS TUBING CONNECTORS
Bio Medicus, Inc.
DTL
May 10, 1988K880831LARGE LUMEN Y ADAPTER W/ROTATING DEVICE
Interventional Medical, Inc.
DTL
Jan 19, 1988K873971ROTATING HEMOSTATIC VALVE
Target Therapeutics
DTL
Oct 7, 1987K873488SILENT GUARD CAT. NO. SG-10
American Omni Medical, Inc.
DTL
Aug 12, 1987K872161DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
Shiley, Inc.
DTL
Apr 27, 1987K870325#014160-TAB TUBING ROTATOR ADAPTOR
Clinical Connections, Inc.
DTL
Feb 20, 1987K870073MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
Clinical Connections, Inc.
DTL
Oct 31, 1986K862451LUER LOCK SKIRT
Hewlett-Packard Co.
DTL
Oct 22, 1986K863402MEDI-PLAST DISPOSABLE MANIFOLD
Medi-Plast Intl., Inc.
DTL
Oct 15, 1986K863177CORDIS ANGIOPLASTY HEMOSTASIS DEVICES
Cordis Corp.
DTL
Sep 29, 1986K863661MEDCOMP DISPOSABLE MANIFOLD SYSTEM
Medical Components, Inc.
DTL
Jul 17, 1986K861783DISPOSABLE STOPCOCK
Utah Medical Products, Inc.
DTL
Mar 31, 1986K860291TUBING CONNECTORS
Biomedical Exports, Inc.
DTL
Feb 10, 1986K854960DISPOSABLE MANIFOLD
Utah Medical Products, Inc.
DTL
Jan 13, 1986K853749CUSTOM CORONARY MANIFOLD KITS
Procedure Products, Inc.
DTL
Jan 8, 1986K854397HEMOSTATIC SIDEARM
Target Therapeutics
DTL
Dec 11, 1985K853950ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
American Bentley
DTL
Dec 4, 1985K854261ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
Advanced Cardiovascular Systems, Inc.
DTL
Dec 3, 1985K853099L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION
L.O.N. Research, Inc.
DTL
Nov 14, 1985K853586PRESSURE SENSING SYRINGE 65000
Dlp, Inc.
DTL
Aug 9, 1985K852086CAPIOX BLOOD SAMPLING MANIFOLD
Terumo Medical Corp.
DTL

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