FDA Product Code
FDA Product Code DTL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4290
510(k) Clearances — 137 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152528 | Attachable Cath Lab Hemostasis Valve | Galt Medical Corp. | 2015-12-02 | Traditional | PDF ↗ |
| K143429 | Passage Hemostasis Valve | Merit Medical Systems, Inc. | 2014-12-22 | Special | PDF ↗ |
| K140475 | ROTATING ADAPTERS | Merit Medical Systems, Inc. | 2014-04-16 | Traditional | PDF ↗ |
| K131124 | COLIGN | Jilin Coronado Medical , Ltd. | 2013-08-28 | Traditional | PDF ↗ |
| K123448 | AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE | Medtronic, Inc. | 2012-12-13 | Special | PDF ↗ |
| K122811 | CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE | Medtronic, Inc. | 2012-10-12 | Special | PDF ↗ |
| K122301 | GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE | Vascular Solutions Zerusa , Ltd. | 2012-09-07 | Traditional | PDF ↗ |
| K120069 | MEDLINE STOPCOCK AND MANIFOLD | Medline Industries, Inc. | 2012-04-03 | Traditional | PDF ↗ |
| K113148 | E-PASS | Synexmed(Shenzhen)Company Limited | 2012-02-28 | Traditional | PDF ↗ |
| K113845 | TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE | Medtronic, Inc. | 2012-01-25 | Special | PDF ↗ |
| K113132 | DISPOSABLE HEMOSTATIC Y-CONNECTORS | Coeur, Inc. | 2012-01-20 | Traditional | PDF ↗ |
| K113667 | CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING | Edwards Lifesciences, LLC | 2012-01-12 | Special | PDF ↗ |
| K101113 | GUARDIAN II NC HEMOSTASIS VALVE | Zerusa Limited | 2010-05-21 | Special | PDF ↗ |
| K093992 | TERUMO LAUER LOCK ADAPTER | Terumo Cardiovascular Systems Corporation | 2010-05-19 | Traditional | PDF ↗ |
| K100319 | MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L | Merit Medical Systems, Inc. | 2010-04-28 | Traditional | PDF ↗ |
| K091634 | NMI FC | Navilyst Medical, Inc. | 2010-03-01 | Abbreviated | PDF ↗ |
| K092563 | GATOR CLIPSEAL PLUG | Vascular Solutions, Inc. | 2009-11-04 | Traditional | PDF ↗ |
| K092711 | GUARDIAN II HEMOSTASIS VALVE | Zerusa Limited | 2009-10-01 | Special | PDF ↗ |
| K080472 | SEDAT MYSHELL LITE | Sedat | 2008-04-23 | Special | PDF ↗ |
| K073260 | LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 | Device Partners International | 2008-03-13 | Abbreviated | PDF ↗ |
| K073474 | CAPIOX CIRCUIT CONNECTORS | Terumo Corp. | 2008-03-05 | Traditional | PDF ↗ |
| K073620 | GUARDIAN HEMOSTASIS VALVE | Zerusa Limited | 2008-02-27 | Traditional | PDF ↗ |
| K072745 | Y-GLIDE | Thomas Medical Products, Inc. | 2008-01-04 | Special | PDF ↗ |
| K072556 | HEMOSTASIS VALVE | Merit Medical Systems, Inc. | 2007-11-20 | Traditional | PDF ↗ |
| K060759 | Y-CLICK CONNECTOR | Elcam Medical Acal | 2006-06-29 | Traditional | PDF ↗ |
| K052459 | 6248VAL ADJUSTABLE VALVE | Medtronic Vascular | 2006-01-11 | Traditional | PDF ↗ |
| K052381 | GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER | Zerusa Limited | 2005-11-21 | Traditional | PDF ↗ |
| K042060 | EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE | Millimed A/S | 2004-10-06 | Traditional | PDF ↗ |
| K041697 | TERUMO CIRCUIT CONNECTORS | Terumo Cardiovascular Systems Corporation | 2004-08-11 | Traditional | PDF ↗ |
| K040498 | MYSHELL | Sedat S.A. | 2004-07-02 | Traditional | PDF ↗ |
| K033328 | NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT | Novosci Corp. | 2004-01-16 | Traditional | PDF ↗ |
| K031688 | RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE | Guidant Corporation | 2003-07-02 | Special | PDF ↗ |
| K031398 | IS-1 HEMOSTASIS VALVE, MODEL 6799 | Guidant Corp. | 2003-05-20 | Special | PDF ↗ |
| K030077 | GISH TUBING AND CONNECTORS WITH GBS COATING | Gish Biomedical, Inc. | 2003-03-14 | Traditional | PDF ↗ |
| K022918 | ADAPTERS WITH X-COATING | Terumo Cardiovascular Systems Corporation | 2002-11-27 | Traditional | PDF ↗ |
| K021282 | LV-1 HEMOSTASIS VALVE, MODEL #6789 | Guidant Corp. | 2002-05-02 | Traditional | PDF ↗ |
| K003604 | ADAPTERS WITH X-COATING | Terumo Cardiovascular Systems Corp. | 2001-02-07 | Traditional | PDF ↗ |
| K992906 | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT | Olson Medical Sales, Inc. | 1999-11-10 | Traditional | PDF ↗ |
| K993057 | MBA | Merit Medical Systems, Inc. | 1999-10-05 | Special | PDF ↗ |
| K991102 | COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 | Guidant Corp. | 1999-06-09 | Traditional | PDF ↗ |
| K972654 | MANIFOLD | Medical Specialties Intl., Inc. | 1997-10-08 | Traditional | PDF ↗ |
| K963749 | HIGH PRESSURE INJECTION LINES | Maxxim Medical | 1996-12-17 | Traditional | PDF ↗ |
| K961181 | NMI VEIN GRAFT PERFUSION SET | Naltiac Medical, Inc. | 1996-06-21 | Traditional | PDF ↗ |
| K955554 | HEMO-VALVE | North American Instrument Corp. | 1996-03-04 | Traditional | PDF ↗ |
| K954284 | MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) | Medi-Plast Intl., Inc. | 1996-02-12 | Traditional | PDF ↗ |
| K953564 | MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE | Medtronic Cardiac Surgery, Medtronic, Inc. | 1996-02-02 | Traditional | PDF ↗ |
| K952531 | QUEST VEIN GRAFT PERFUSION SET | Quest Medical, Inc. | 1995-08-24 | Traditional | PDF ↗ |
| K942391 | BRAUN MANIFOLD | B.Braun Medical, Inc. | 1995-06-21 | Traditional | PDF ↗ |
| K951089 | SCIMED GATEWAY PLUS | Scimed Life Systems, Inc. | 1995-05-31 | Traditional | PDF ↗ |
| K945931 | RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE | Research Industries Corp. | 1995-03-03 | Traditional | PDF ↗ |
| K945461 | PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) | Medtronics Interventional Vascular | 1995-02-03 | Traditional | PDF ↗ |
| K911884 | ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES | Advance Medical Designs, Inc. | 1994-07-05 | Traditional | PDF ↗ |
| K933084 | CHECK VALVE (FITTING) | Merit Medical Systems, Inc. | 1994-03-23 | Traditional | PDF ↗ |
| K934123 | STOPCOCK (ONE-PORT MANIFOLD) | Merit Medical Systems, Inc. | 1993-11-23 | Traditional | PDF ↗ |
| K922840 | ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS | Gish Biomedical, Inc. | 1993-05-17 | Traditional | PDF ↗ |
| K925419 | PASSAGE HEMOSTASIS VALVE | Merit Medical Systems, Inc. | 1993-01-22 | Traditional | PDF ↗ |
| K915301 | ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK | Advance Medical Designs, Inc. | 1992-12-11 | Traditional | PDF ↗ |
| K914987 | HIGH PRESSURE CONNECTING SETS, MODIFICATION | E-Z-Em, Inc. | 1992-05-20 | Traditional | PDF ↗ |
| K913363 | CUSTOM TUBING PACKS | Kroy Medical, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K912969 | TORQUE FITTING | Freedom Machine, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K913161 | MERIT MANIFOLD | Merit Medical Systems, Inc. | 1991-10-21 | Traditional | PDF ↗ |
| K912709 | MX 339 TWIN HEMOSTATIC Y CONNECTOR | Medex, Inc. | 1991-09-11 | Traditional | PDF ↗ |
| K910845 | ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012 | Interventional Therapeutics Corp. | 1991-05-21 | Traditional | PDF ↗ |
| K902741 | VASCUMED EZ Y-CONNECTOR | Vascumed Systems | 1990-11-01 | Traditional | PDF ↗ |
| K900994 | ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT. | Dlp, Inc. | 1990-08-15 | Traditional | PDF ↗ |
| K900652 | NAMIC PTCA Y-ADAPTOR | North American Instrument Corp. | 1990-06-26 | Traditional | PDF ↗ |
| K897137 | RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING | Research Medical, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K897196 | ADVANCE STOPCOCKS ADVANCE MANIFOLDS | Advance Medical Designs, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K897197 | ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. | Advance Medical Designs, Inc. | 1990-03-19 | Traditional | PDF ↗ |
| K895795 | HPD TUBING CONNECTORS | Hpd Medical, Inc. | 1990-01-26 | Traditional | PDF ↗ |
| K892377 | RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET | Research Medical, Inc. | 1989-12-07 | Traditional | PDF ↗ |
| K892368 | RMI CARDIOPLEGIA DELIVERY SETS | Research Medical, Inc. | 1989-12-07 | Traditional | PDF ↗ |
| K893683 | SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM | 3M Company | 1989-08-03 | Traditional | PDF ↗ |
| K891572 | ANGIOGRAPHY CUSTOM PACKS | Procedure Packs, Inc. | 1989-07-24 | Traditional | PDF ↗ |
| K890676 | DISPOSABLE TRANSDUCER MANIFOLD | L.O.N. Research, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K890580 | LIPID STOPCOCK | North American Instrument Corp. | 1989-04-19 | Traditional | PDF ↗ |
| K884408 | NAMIC DUAL BACKCHECK VALVE | North American Instrument Corp. | 1989-01-12 | Traditional | PDF ↗ |
| K882717 | PROCEDURE PACKS CONTRAST MEDIA SETS | Procedure Packs, Inc. | 1988-12-28 | Traditional | PDF ↗ |
| K884200 | USCI TANDEM ADAPTER | C.R. Bard, Inc. | 1988-12-05 | Traditional | PDF ↗ |
| K883956 | BIO-MEDICUS TUBING CONNECTORS | Bio Medicus, Inc. | 1988-10-28 | Traditional | PDF ↗ |
| K880831 | LARGE LUMEN Y ADAPTER W/ROTATING DEVICE | Interventional Medical, Inc. | 1988-05-10 | Traditional | PDF ↗ |
| K873971 | ROTATING HEMOSTATIC VALVE | Target Therapeutics | 1988-01-19 | Traditional | PDF ↗ |
| K873488 | SILENT GUARD CAT. NO. SG-10 | American Omni Medical, Inc. | 1987-10-07 | Traditional | PDF ↗ |
| K872161 | DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET | Shiley, Inc. | 1987-08-12 | Traditional | PDF ↗ |
| K870325 | #014160-TAB TUBING ROTATOR ADAPTOR | Clinical Connections, Inc. | 1987-04-27 | Traditional | PDF ↗ |
| K870073 | MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB | Clinical Connections, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K862451 | LUER LOCK SKIRT | Hewlett-Packard Co. | 1986-10-31 | Traditional | PDF ↗ |
| K863402 | MEDI-PLAST DISPOSABLE MANIFOLD | Medi-Plast Intl., Inc. | 1986-10-22 | Traditional | PDF ↗ |
| K863177 | CORDIS ANGIOPLASTY HEMOSTASIS DEVICES | Cordis Corp. | 1986-10-15 | Traditional | PDF ↗ |
| K863661 | MEDCOMP DISPOSABLE MANIFOLD SYSTEM | Medical Components, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K861783 | DISPOSABLE STOPCOCK | Utah Medical Products, Inc. | 1986-07-17 | Traditional | PDF ↗ |
| K860291 | TUBING CONNECTORS | Biomedical Exports, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K854960 | DISPOSABLE MANIFOLD | Utah Medical Products, Inc. | 1986-02-10 | Traditional | PDF ↗ |
| K853749 | CUSTOM CORONARY MANIFOLD KITS | Procedure Products, Inc. | 1986-01-13 | Traditional | PDF ↗ |
| K854397 | HEMOSTATIC SIDEARM | Target Therapeutics | 1986-01-08 | Traditional | PDF ↗ |
| K853950 | ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL | American Bentley | 1985-12-11 | Traditional | PDF ↗ |
| K854261 | ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES | Advanced Cardiovascular Systems, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K853099 | L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION | L.O.N. Research, Inc. | 1985-12-03 | Traditional | PDF ↗ |
| K853586 | PRESSURE SENSING SYRINGE 65000 | Dlp, Inc. | 1985-11-14 | Traditional | PDF ↗ |
| K852086 | CAPIOX BLOOD SAMPLING MANIFOLD | Terumo Medical Corp. | 1985-08-09 | Traditional | PDF ↗ |
Product code DTL · Class II · Cardiovascular. Data: openFDA.