Product code DTL
- Device name
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4290
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152528 | Attachable Cath Lab Hemostasis Valve | Galt Medical Corp. | 2015-12-02 |
| K143429 | Passage Hemostasis Valve | Merit Medical Systems, Inc. | 2014-12-22 |
| K140475 | ROTATING ADAPTERS | Merit Medical Systems, Inc. | 2014-04-16 |
| K131124 | COLIGN | Jilin Coronado Medical , Ltd. | 2013-08-28 |
| K123448 | AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE | Medtronic, Inc. | 2012-12-13 |
| K122811 | CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE | Medtronic, Inc. | 2012-10-12 |
| K122301 | GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE | Vascular Solutions Zerusa , Ltd. | 2012-09-07 |
| K120069 | MEDLINE STOPCOCK AND MANIFOLD | Medline Industries, Inc. | 2012-04-03 |
| K113148 | E-PASS | Synexmed(Shenzhen)Company Limited | 2012-02-28 |
| K113845 | TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE | Medtronic, Inc. | 2012-01-25 |
| K113132 | DISPOSABLE HEMOSTATIC Y-CONNECTORS | Coeur, Inc. | 2012-01-20 |
| K113667 | CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING | Edwards Lifesciences, LLC | 2012-01-12 |
| K101113 | GUARDIAN II NC HEMOSTASIS VALVE | Zerusa Limited | 2010-05-21 |
| K093992 | TERUMO LAUER LOCK ADAPTER | Terumo Cardiovascular Systems Corporation | 2010-05-19 |
| 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 |
| K091634 | NMI FC | Navilyst Medical, Inc. | 2010-03-01 |
| K092563 | GATOR CLIPSEAL PLUG | Vascular Solutions, Inc. | 2009-11-04 |
| K092711 | GUARDIAN II HEMOSTASIS VALVE | Zerusa Limited | 2009-10-01 |
| K080472 | SEDAT MYSHELL LITE | Sedat | 2008-04-23 |
| K073260 | LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 | Device Partners International | 2008-03-13 |
| K073474 | CAPIOX CIRCUIT CONNECTORS | Terumo Corp. | 2008-03-05 |
| K073620 | GUARDIAN HEMOSTASIS VALVE | Zerusa Limited | 2008-02-27 |
| K072745 | Y-GLIDE | Thomas Medical Products, Inc. | 2008-01-04 |
| K072556 | HEMOSTASIS VALVE | Merit Medical Systems, Inc. | 2007-11-20 |
| K060759 | Y-CLICK CONNECTOR | Elcam Medical Acal | 2006-06-29 |
| K052459 | 6248VAL ADJUSTABLE VALVE | Medtronic Vascular | 2006-01-11 |
| K052381 | GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER | Zerusa Limited | 2005-11-21 |
| K042060 | EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE | Millimed A/S | 2004-10-06 |
| K041697 | TERUMO CIRCUIT CONNECTORS | Terumo Cardiovascular Systems Corporation | 2004-08-11 |
| K040498 | MYSHELL | Sedat S.A. | 2004-07-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327459210 | AXS VECTA 71 | Stryker Corporation | 2018-10-26 |
| 07613327459227 | AXS VECTA 71 | Stryker Corporation | 2018-10-26 |
| 07613327459234 | AXS VECTA 71 | Stryker Corporation | 2018-10-26 |
| 07613327459180 | AXS INFINITY LS PLUS | Stryker Corporation | 2018-10-08 |
| 07613327459197 | AXS INFINITY LS PLUS | Stryker Corporation | 2018-10-08 |
| 07613327459203 | AXS INFINITY LS PLUS | Stryker Corporation | 2018-10-08 |
| 08714729965787 | WATCHDOG™ | BOSTON SCIENTIFIC CORPORATION | 2017-09-12 |
| 08714729071280 | GateWay™ PLUS | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729734604 | GateWay™ PLUS | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| H6714003510 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H6719026380 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| 07613327064711 | Rotating Hemostatic Valve | Stryker Corporation | 2016-09-21 |
| H749800384020 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800383130 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800383030 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800383010 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800382020 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800382000 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800374140 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800374040 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800374020 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800373130 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800373030 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800372120 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800372000 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800363030 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800363010 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800362020 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749800362000 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-17 |
| H749700271800 | NAMIC | NAVILYST MEDICAL, INC. | 2015-09-16 |