Product Code: DTL FDA class 2 21 CFR 870.4290

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cardiovascular

The Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, and Fitting is a cardiovascular accessory device used to connect, route, and control the flow of blood and fluids within extracorporeal bypass circuits during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTL and it is regulated under 21 CFR 870.4290 within the Cardiovascular medical specialty.

View on FDA

510(k)s

137

FEI Numbers

143

Registration Numbers

144

Unique Applicants

Years Active

Basic Information

Product Code: DTL
Device Class: FDA class 2
Regulation Number: 870.4290
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 137 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K152528	Attachable Cath Lab Hemostasis Valve	Dec 02, 2015	Substantially Equivalent	Galt Medical Corp.
K143429	Passage Hemostasis Valve	Dec 22, 2014	Substantially Equivalent	Merit Medical Systems, Inc.
K140475	ROTATING ADAPTERS	Apr 16, 2014	Substantially Equivalent	Merit Medical Systems, Inc.
K131124	COLIGN	Aug 28, 2013	Substantially Equivalent	Jilin Coronado Medical , Ltd.
K123448	AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE	Dec 13, 2012	Substantially Equivalent	Medtronic, Inc.
K122811	CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE	Oct 12, 2012	Substantially Equivalent	Medtronic, Inc.
K122301	GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE	Sep 07, 2012	Substantially Equivalent	Vascular Solutions Zerusa , Ltd.
K120069	MEDLINE STOPCOCK AND MANIFOLD	Apr 03, 2012	Substantially Equivalent	Medline Industries, Inc.
K113148	E-PASS	Feb 28, 2012	Substantially Equivalent	Synexmed(Shenzhen)Company Limited
K113845	TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE	Jan 25, 2012	Substantially Equivalent	Medtronic, Inc.
K113132	DISPOSABLE HEMOSTATIC Y-CONNECTORS	Jan 20, 2012	Substantially Equivalent	Coeur, Inc.
K113667	CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING	Jan 12, 2012	Substantially Equivalent	Edwards Lifesciences, LLC
K101113	GUARDIAN II NC HEMOSTASIS VALVE	May 21, 2010	Substantially Equivalent	Zerusa Limited
K093992	TERUMO LAUER LOCK ADAPTER	May 19, 2010	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K100319	MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L	Apr 28, 2010	Substantially Equivalent	Merit Medical Systems, Inc.
K091634	NMI FC	Mar 01, 2010	Substantially Equivalent	Navilyst Medical, Inc.
K092563	GATOR CLIPSEAL PLUG	Nov 04, 2009	Substantially Equivalent	Vascular Solutions, Inc.
K092711	GUARDIAN II HEMOSTASIS VALVE	Oct 01, 2009	Substantially Equivalent	Zerusa Limited
K080472	SEDAT MYSHELL LITE	Apr 23, 2008	Substantially Equivalent	Sedat
K073260	LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109	Mar 13, 2008	Substantially Equivalent	Device Partners International
K073474	CAPIOX CIRCUIT CONNECTORS	Mar 05, 2008	Substantially Equivalent	Terumo Corp.
K073620	GUARDIAN HEMOSTASIS VALVE	Feb 27, 2008	Substantially Equivalent	Zerusa Limited
K072745	Y-GLIDE	Jan 04, 2008	Substantially Equivalent	Thomas Medical Products, Inc.
K072556	HEMOSTASIS VALVE	Nov 20, 2007	Substantially Equivalent	Merit Medical Systems, Inc.
K060759	Y-CLICK CONNECTOR	Jun 29, 2006	Substantially Equivalent	Elcam Medical Acal
K052459	6248VAL ADJUSTABLE VALVE	Jan 11, 2006	Substantially Equivalent	Medtronic Vascular
K052381	GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER	Nov 21, 2005	Substantially Equivalent	Zerusa Limited
K042060	EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE	Oct 06, 2004	Substantially Equivalent	Millimed A/S
K041697	TERUMO CIRCUIT CONNECTORS	Aug 11, 2004	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K040498	MYSHELL	Jul 02, 2004	Substantially Equivalent	Sedat S.A.
K033328	NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT	Jan 16, 2004	Substantially Equivalent	Novosci Corp.
K031688	RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE	Jul 02, 2003	Substantially Equivalent	Guidant Corporation
K031398	IS-1 HEMOSTASIS VALVE, MODEL 6799	May 20, 2003	Substantially Equivalent	Guidant Corp.
K030077	GISH TUBING AND CONNECTORS WITH GBS COATING	Mar 14, 2003	Substantially Equivalent	Gish Biomedical, Inc.
K022918	ADAPTERS WITH X-COATING	Nov 27, 2002	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K021282	LV-1 HEMOSTASIS VALVE, MODEL #6789	May 02, 2002	Substantially Equivalent	Guidant Corp.
K003604	ADAPTERS WITH X-COATING	Feb 07, 2001	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K992906	COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT	Nov 10, 1999	Substantially Equivalent	Olson Medical Sales, Inc.
K993057	MBA	Oct 05, 1999	Substantially Equivalent	Merit Medical Systems, Inc.
K991102	COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331	Jun 09, 1999	Substantially Equivalent	Guidant Corp.
K972654	MANIFOLD	Oct 08, 1997	Substantially Equivalent	Medical Specialties Intl., Inc.
K963749	HIGH PRESSURE INJECTION LINES	Dec 17, 1996	Substantially Equivalent	Maxxim Medical
K961181	NMI VEIN GRAFT PERFUSION SET	Jun 21, 1996	Substantially Equivalent	Naltiac Medical, Inc.
K955554	HEMO-VALVE	Mar 04, 1996	Substantially Equivalent	North American Instrument Corp.
K954284	MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)	Feb 12, 1996	Substantially Equivalent	Medi-Plast Intl., Inc.
K953564	MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE	Feb 02, 1996	Substantially Equivalent	Medtronic Cardiac Surgery, Medtronic, Inc.
K952531	QUEST VEIN GRAFT PERFUSION SET	Aug 24, 1995	Substantially Equivalent	Quest Medical, Inc.
K942391	BRAUN MANIFOLD	Jun 21, 1995	Substantially Equivalent	B.Braun Medical, Inc.
K951089	SCIMED GATEWAY PLUS	May 31, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K945931	RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE	Mar 03, 1995	Substantially Equivalent	Research Industries Corp.
K945461	PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)	Feb 03, 1995	Substantially Equivalent	Medtronics Interventional Vascular
K911884	ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES	Jul 05, 1994	Substantially Equivalent	Advance Medical Designs, Inc.
K933084	CHECK VALVE (FITTING)	Mar 23, 1994	Substantially Equivalent	Merit Medical Systems, Inc.
K934123	STOPCOCK (ONE-PORT MANIFOLD)	Nov 23, 1993	Substantially Equivalent	Merit Medical Systems, Inc.
K922840	ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS	May 17, 1993	Substantially Equivalent	Gish Biomedical, Inc.
K925419	PASSAGE HEMOSTASIS VALVE	Jan 22, 1993	Substantially Equivalent	Merit Medical Systems, Inc.
K915301	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	Dec 11, 1992	Substantially Equivalent	Advance Medical Designs, Inc.
K914987	HIGH PRESSURE CONNECTING SETS, MODIFICATION	May 20, 1992	Substantially Equivalent	E-Z-Em, Inc.
K913363	CUSTOM TUBING PACKS	Dec 20, 1991	Substantially Equivalent	Kroy Medical, Inc.
K912969	TORQUE FITTING	Nov 05, 1991	Substantially Equivalent	Freedom Machine, Inc.
K913161	MERIT MANIFOLD	Oct 21, 1991	Substantially Equivalent	Merit Medical Systems, Inc.
K912709	MX 339 TWIN HEMOSTATIC Y CONNECTOR	Sep 11, 1991	Substantially Equivalent	Medex, Inc.
K910845	ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012	May 21, 1991	Substantially Equivalent	Interventional Therapeutics Corp.
K902741	VASCUMED EZ Y-CONNECTOR	Nov 01, 1990	Substantially Equivalent	Vascumed Systems
K900994	ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.	Aug 15, 1990	Substantially Equivalent	Dlp, Inc.
K900652	NAMIC PTCA Y-ADAPTOR	Jun 26, 1990	Substantially Equivalent	North American Instrument Corp.
K897196	ADVANCE STOPCOCKS ADVANCE MANIFOLDS	Mar 27, 1990	Substantially Equivalent	Advance Medical Designs, Inc.
K897137	RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING	Mar 27, 1990	Substantially Equivalent	Research Medical, Inc.
K897197	ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.	Mar 19, 1990	Substantially Equivalent	Advance Medical Designs, Inc.
K895795	HPD TUBING CONNECTORS	Jan 26, 1990	Substantially Equivalent	Hpd Medical, Inc.
K892377	RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET	Dec 07, 1989	Substantially Equivalent	Research Medical, Inc.
K892368	RMI CARDIOPLEGIA DELIVERY SETS	Dec 07, 1989	Substantially Equivalent	Research Medical, Inc.
K893683	SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM	Aug 03, 1989	Substantially Equivalent	3M Company
K891572	ANGIOGRAPHY CUSTOM PACKS	Jul 24, 1989	Substantially Equivalent	Procedure Packs, Inc.
K890676	DISPOSABLE TRANSDUCER MANIFOLD	Jul 14, 1989	Substantially Equivalent	L.O.N. Research, Inc.
K890580	LIPID STOPCOCK	Apr 19, 1989	Substantially Equivalent	North American Instrument Corp.
K884408	NAMIC DUAL BACKCHECK VALVE	Jan 12, 1989	Substantially Equivalent	North American Instrument Corp.
K882717	PROCEDURE PACKS CONTRAST MEDIA SETS	Dec 28, 1988	Substantially Equivalent	Procedure Packs, Inc.
K884200	USCI TANDEM ADAPTER	Dec 05, 1988	Substantially Equivalent	C.R. Bard, Inc.
K883956	BIO-MEDICUS TUBING CONNECTORS	Oct 28, 1988	Substantially Equivalent	Bio Medicus, Inc.
K880831	LARGE LUMEN Y ADAPTER W/ROTATING DEVICE	May 10, 1988	Substantially Equivalent	Interventional Medical, Inc.
K873971	ROTATING HEMOSTATIC VALVE	Jan 19, 1988	Substantially Equivalent	Target Therapeutics
K873488	SILENT GUARD CAT. NO. SG-10	Oct 07, 1987	Substantially Equivalent	American Omni Medical, Inc.
K872161	DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET	Aug 12, 1987	Substantially Equivalent	Shiley, Inc.
K870325	#014160-TAB TUBING ROTATOR ADAPTOR	Apr 27, 1987	Substantially Equivalent	Clinical Connections, Inc.
K870073	MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB	Feb 20, 1987	Substantially Equivalent	Clinical Connections, Inc.
K862451	LUER LOCK SKIRT	Oct 31, 1986	Substantially Equivalent	Hewlett-Packard Co.
K863402	MEDI-PLAST DISPOSABLE MANIFOLD	Oct 22, 1986	Substantially Equivalent	Medi-Plast Intl., Inc.
K863177	CORDIS ANGIOPLASTY HEMOSTASIS DEVICES	Oct 15, 1986	Substantially Equivalent	Cordis Corp.
K863661	MEDCOMP DISPOSABLE MANIFOLD SYSTEM	Sep 29, 1986	Substantially Equivalent	Medical Components, Inc.
K861783	DISPOSABLE STOPCOCK	Jul 17, 1986	Substantially Equivalent	Utah Medical Products, Inc.
K860291	TUBING CONNECTORS	Mar 31, 1986	Substantially Equivalent	Biomedical Exports, Inc.
K854960	DISPOSABLE MANIFOLD	Feb 10, 1986	Substantially Equivalent	Utah Medical Products, Inc.
K853749	CUSTOM CORONARY MANIFOLD KITS	Jan 13, 1986	Substantially Equivalent	Procedure Products, Inc.
K854397	HEMOSTATIC SIDEARM	Jan 08, 1986	Substantially Equivalent	Target Therapeutics
K853950	ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL	Dec 11, 1985	Substantially Equivalent	American Bentley
K854261	ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES	Dec 04, 1985	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K853099	L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION	Dec 03, 1985	Substantially Equivalent	L.O.N. Research, Inc.
K853586	PRESSURE SENSING SYRINGE 65000	Nov 14, 1985	Substantially Equivalent	Dlp, Inc.
K852086	CAPIOX BLOOD SAMPLING MANIFOLD	Aug 09, 1985	Substantially Equivalent	Terumo Medical Corp.
K851465	SILENT GUARD CAT. NO. SG-30	Aug 05, 1985	Substantially Equivalent	American Omni Medical, Inc.
K852118	MANIFOLD CLAMPS	Jun 06, 1985	Substantially Equivalent	Omser Sv., Inc.
K833644	FILTER PURGE LINE EC-FPL SERIES	Dec 29, 1984	Substantially Equivalent	Gish Biomedical, Inc.
K842829	HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS	Oct 18, 1984	Substantially Equivalent	North American Instrument Corp.
K840797	MALE-MALE LUER LOCK CONNECTOR W/ROTA	Apr 24, 1984	Substantially Equivalent	American Pharmaseal Div. Ahsc
K840603	ARTERIAL FILTER PURGE LINE W/CHECK VALV	Apr 19, 1984	Substantially Equivalent	Shiley, Inc.
K833322	TUBING CONNECTORS EC-2XXX SERIES	Dec 16, 1983	Substantially Equivalent	Gish Biomedical, Inc.
K832625	TOP THREE WAY STOPCOCK	Oct 19, 1983	Substantially Equivalent	Top Surgical Manufacturers Co.
K831261	SCI MED TUBING CONNECTORS	Jun 03, 1983	Substantially Equivalent	Scimed Life Systems, Inc.
K831260	SCI MED TEMPERATURE MONITORING ADAPTOR	Jun 03, 1983	Substantially Equivalent	Scimed Life Systems, Inc.
K820864	NORTON MANIFOLD	Apr 15, 1982	Substantially Equivalent	Norton Performance Plastics Corp.
K820297	WM. HARVEY OVERPRESSURE SAFETY VALVE	Mar 12, 1982	Substantially Equivalent	C.R. Bard, Inc.
K812408	L.O.N. DISPOSABLE CORONARY MANIFOLD	Dec 02, 1981	Substantially Equivalent	L.O.N. Research, Inc.
K812407	L.O.N. REUSABLE MANIFOLDS & STOPCOCKS	Dec 02, 1981	Substantially Equivalent	L.O.N. Research, Inc.
K813141	VYGON STOPCOCKS & RAMPS(MANIFOLDS)	Nov 27, 1981	Substantially Equivalent	Exco, Inc.
K802544	DISPOSABLE QUICK RELEASE PERFUSION ADAP	Jan 16, 1981	Substantially Equivalent	Texas Medical Products, Inc.
K801828	MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS	Aug 27, 1980	Substantially Equivalent	Graphic Controls Corp.
K801405	DISPOSABLE PERFUSION CONNECTORS	Jun 30, 1980	Substantially Equivalent	Texas Medical Products, Inc.
K801404	DISPOSABLE PARALLEL Y CONNECTORS	Jun 30, 1980	Substantially Equivalent	Texas Medical Products, Inc.
K801402	QUICKIE PRIME CARDIOP. BYPASS PERF. INTR	Jun 30, 1980	Substantially Equivalent	Texas Medical Products, Inc.
K801399	CORONARY PERFUSION CONNECTOR PLUG	Jun 30, 1980	Substantially Equivalent	Texas Medical Products, Inc.
K801200	SAMPLING MANIFOLD H530	Jun 04, 1980	Substantially Equivalent	C.R. Bard, Inc.
K800880	PLASTIC TUBING ADAPTERS 5-IN-1-	May 14, 1980	Substantially Equivalent	Harvard Laboratories
K792113	CONPHAR MANOMETER CONNECTORS	Dec 05, 1979	Substantially Equivalent	Conphar, Inc.
K791914	3-WAY STOPCOCK W/MALE LOCKING LUER ADA.	Oct 11, 1979	Substantially Equivalent	Abbott Laboratories
K791797	MTS CATHETER ADAPTER FOR GUIDANCE ENTRY	Oct 11, 1979	Substantially Equivalent	Medical Testing System, Inc.
K791498	ADAPTER-Y TYPE/CORONARY PERFUSION	Aug 28, 1979	Substantially Equivalent	Dlp, Inc.
K791107	STOPCOCK, THREE WAY	Jun 22, 1979	Substantially Equivalent	Norton Performance Plastics Corp.
K790804	PURGE LINE UNIT	May 25, 1979	Substantially Equivalent	Surgikos, Inc.
K790564	ADAPTER-STRAIGHT	Apr 12, 1979	Substantially Equivalent	Dlp, Inc.
K790563	ADAPTERS-Y-TYPE	Apr 12, 1979	Substantially Equivalent	Dlp, Inc.
K782095	STOPCOCKS, MANIFOLDS	Jan 23, 1979	Substantially Equivalent	Namic
K781579	MODIFIED STERILE DISPOSABLE STOPCOCKS	Oct 05, 1978	Substantially Equivalent	Cobe Laboratories, Inc.
K780271	COBE STOPCOCK	Mar 02, 1978	Substantially Equivalent	Cobe Laboratories, Inc.
K780056	OXYGENATOR HOLDER	Feb 01, 1978	Substantially Equivalent	C.R. Bard, Inc.
K772299	TRANSPARENT MANIFOLD	Dec 21, 1977	Substantially Equivalent	Uni-Research
K760843	PALEY TRANSPARENT MANIFOLD	Nov 12, 1976	Substantially Equivalent	Usci, Div. C.R. Bard, Inc.