Atlas FDA

DTL

137 FDA 510(k) clearances · Product code

78 daysmedian time to decision
166 days90th percentile
137clearances measured

FDA profile

Official device name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4290
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 55 · 2022: 48 · 2023: 46 · 2024: 452 · 2025: 113 · 2026: 93
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Attachable Cath Lab Hemostasis Valve (K152528)Galt Medical Corp.2015-12-02
Passage Hemostasis Valve (K143429)Merit Medical Systems, Inc.2014-12-22
ROTATING ADAPTERS (K140475)Merit Medical Systems, Inc.2014-04-16
COLIGN (K131124)Jilin Coronado Medical , Ltd.2013-08-28
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE (K123448)Medtronic, Inc.2012-12-13
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (K122811)Medtronic, Inc.2012-10-12
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (K122301)Vascular Solutions Zerusa , Ltd.2012-09-07
MEDLINE STOPCOCK AND MANIFOLD (K120069)Medline Industries, Inc.2012-04-03
E-PASS (K113148)Synexmed(Shenzhen)Company Limited2012-02-28
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (K113845)Medtronic, Inc.2012-01-25
DISPOSABLE HEMOSTATIC Y-CONNECTORS (K113132)Coeur, Inc.2012-01-20
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING (K113667)Edwards Lifesciences, LLC2012-01-12
GUARDIAN II NC HEMOSTASIS VALVE (K101113)Zerusa Limited2010-05-21
TERUMO LAUER LOCK ADAPTER (K093992)Terumo Cardiovascular Systems Corporation2010-05-19
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L (K100319)Merit Medical Systems, Inc.2010-04-28
NMI FC (K091634)Navilyst Medical, Inc.2010-03-01
GATOR CLIPSEAL PLUG (K092563)Vascular Solutions, Inc.2009-11-04
GUARDIAN II HEMOSTASIS VALVE (K092711)Zerusa Limited2009-10-01
SEDAT MYSHELL LITE (K080472)Sedat2008-04-23
LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 (K073260)Device Partners International2008-03-13
CAPIOX CIRCUIT CONNECTORS (K073474)Terumo Corp.2008-03-05
GUARDIAN HEMOSTASIS VALVE (K073620)Zerusa Limited2008-02-27
Y-GLIDE (K072745)Thomas Medical Products, Inc.2008-01-04
HEMOSTASIS VALVE (K072556)Merit Medical Systems, Inc.2007-11-20
Y-CLICK CONNECTOR (K060759)Elcam Medical Acal2006-06-29
6248VAL ADJUSTABLE VALVE (K052459)Medtronic Vascular2006-01-11
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER (K052381)Zerusa Limited2005-11-21
EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE (K042060)Millimed A/S2004-10-06
TERUMO CIRCUIT CONNECTORS (K041697)Terumo Cardiovascular Systems Corporation2004-08-11
MYSHELL (K040498)Sedat S.A.2004-07-02
NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT (K033328)Novosci Corp.2004-01-16
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE (K031688)Guidant Corporation2003-07-02
IS-1 HEMOSTASIS VALVE, MODEL 6799 (K031398)Guidant Corp.2003-05-20
GISH TUBING AND CONNECTORS WITH GBS COATING (K030077)Gish Biomedical, Inc.2003-03-14
ADAPTERS WITH X-COATING (K022918)Terumo Cardiovascular Systems Corporation2002-11-27
LV-1 HEMOSTASIS VALVE, MODEL #6789 (K021282)Guidant Corp.2002-05-02
ADAPTERS WITH X-COATING (K003604)Terumo Cardiovascular Systems Corp.2001-02-07
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT (K992906)Olson Medical Sales, Inc.1999-11-10
MBA (K993057)Merit Medical Systems, Inc.1999-10-05
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 (K991102)Guidant Corp.1999-06-09
MANIFOLD (K972654)Medical Specialties Intl., Inc.1997-10-08
HIGH PRESSURE INJECTION LINES (K963749)Maxxim Medical1996-12-17
NMI VEIN GRAFT PERFUSION SET (K961181)Naltiac Medical, Inc.1996-06-21
HEMO-VALVE (K955554)North American Instrument Corp.1996-03-04
MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) (K954284)Medi-Plast Intl., Inc.1996-02-12
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE (K953564)Medtronic Cardiac Surgery, Medtronic, Inc.1996-02-02
QUEST VEIN GRAFT PERFUSION SET (K952531)Quest Medical, Inc.1995-08-24
BRAUN MANIFOLD (K942391)B.Braun Medical, Inc.1995-06-21
SCIMED GATEWAY PLUS (K951089)Scimed Life Systems, Inc.1995-05-31
RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE (K945931)Research Industries Corp.1995-03-03
PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) (K945461)Medtronics Interventional Vascular1995-02-03
ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES (K911884)Advance Medical Designs, Inc.1994-07-05
CHECK VALVE (FITTING) (K933084)Merit Medical Systems, Inc.1994-03-23
STOPCOCK (ONE-PORT MANIFOLD) (K934123)Merit Medical Systems, Inc.1993-11-23
ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS (K922840)Gish Biomedical, Inc.1993-05-17
PASSAGE HEMOSTASIS VALVE (K925419)Merit Medical Systems, Inc.1993-01-22
ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK (K915301)Advance Medical Designs, Inc.1992-12-11
HIGH PRESSURE CONNECTING SETS, MODIFICATION (K914987)E-Z-Em, Inc.1992-05-20
CUSTOM TUBING PACKS (K913363)Kroy Medical, Inc.1991-12-20
TORQUE FITTING (K912969)Freedom Machine, Inc.1991-11-05
MERIT MANIFOLD (K913161)Merit Medical Systems, Inc.1991-10-21
MX 339 TWIN HEMOSTATIC Y CONNECTOR (K912709)Medex, Inc.1991-09-11
ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012 (K910845)Interventional Therapeutics Corp.1991-05-21
VASCUMED EZ Y-CONNECTOR (K902741)Vascumed Systems1990-11-01
ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT. (K900994)Dlp, Inc.1990-08-15
NAMIC PTCA Y-ADAPTOR (K900652)North American Instrument Corp.1990-06-26
RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING (K897137)Research Medical, Inc.1990-03-27
ADVANCE STOPCOCKS ADVANCE MANIFOLDS (K897196)Advance Medical Designs, Inc.1990-03-27
ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. (K897197)Advance Medical Designs, Inc.1990-03-19
HPD TUBING CONNECTORS (K895795)Hpd Medical, Inc.1990-01-26
RMI CARDIOPLEGIA DELIVERY SETS (K892368)Research Medical, Inc.1989-12-07
RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET (K892377)Research Medical, Inc.1989-12-07
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM (K893683)3M Company1989-08-03
ANGIOGRAPHY CUSTOM PACKS (K891572)Procedure Packs, Inc.1989-07-24
DISPOSABLE TRANSDUCER MANIFOLD (K890676)L.O.N. Research, Inc.1989-07-14
LIPID STOPCOCK (K890580)North American Instrument Corp.1989-04-19
NAMIC DUAL BACKCHECK VALVE (K884408)North American Instrument Corp.1989-01-12
PROCEDURE PACKS CONTRAST MEDIA SETS (K882717)Procedure Packs, Inc.1988-12-28
USCI TANDEM ADAPTER (K884200)C.R. Bard, Inc.1988-12-05
BIO-MEDICUS TUBING CONNECTORS (K883956)Bio Medicus, Inc.1988-10-28
LARGE LUMEN Y ADAPTER W/ROTATING DEVICE (K880831)Interventional Medical, Inc.1988-05-10
ROTATING HEMOSTATIC VALVE (K873971)Target Therapeutics1988-01-19
SILENT GUARD CAT. NO. SG-10 (K873488)American Omni Medical, Inc.1987-10-07
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET (K872161)Shiley, Inc.1987-08-12
#014160-TAB TUBING ROTATOR ADAPTOR (K870325)Clinical Connections, Inc.1987-04-27
MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB (K870073)Clinical Connections, Inc.1987-02-20
LUER LOCK SKIRT (K862451)Hewlett-Packard Co.1986-10-31
MEDI-PLAST DISPOSABLE MANIFOLD (K863402)Medi-Plast Intl., Inc.1986-10-22
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES (K863177)Cordis Corp.1986-10-15
MEDCOMP DISPOSABLE MANIFOLD SYSTEM (K863661)Medical Components, Inc.1986-09-29
DISPOSABLE STOPCOCK (K861783)Utah Medical Products, Inc.1986-07-17
TUBING CONNECTORS (K860291)Biomedical Exports, Inc.1986-03-31
DISPOSABLE MANIFOLD (K854960)Utah Medical Products, Inc.1986-02-10
CUSTOM CORONARY MANIFOLD KITS (K853749)Procedure Products, Inc.1986-01-13
HEMOSTATIC SIDEARM (K854397)Target Therapeutics1986-01-08
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL (K853950)American Bentley1985-12-11
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES (K854261)Advanced Cardiovascular Systems, Inc.1985-12-04
L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION (K853099)L.O.N. Research, Inc.1985-12-03
PRESSURE SENSING SYRINGE 65000 (K853586)Dlp, Inc.1985-11-14
CAPIOX BLOOD SAMPLING MANIFOLD (K852086)Terumo Medical Corp.1985-08-09
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