DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Class II
FDA product code DTL covers "Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4290. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTL
- Device Class
- Class II
- Regulation Number
- 870.4290
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K152528 | galt medical | Attachable Cath Lab Hemostasis Valve | December 2, 2015 |
| K143429 | merit medical systems | Passage Hemostasis Valve | December 22, 2014 |
| K140475 | merit medical systems | ROTATING ADAPTERS | April 16, 2014 |
| K131124 | jilin coronado medical | COLIGN | August 28, 2013 |
| K123448 | medtronic | AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE L | December 13, 2012 |
| K122811 | medtronic | CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE | October 12, 2012 |
| K122301 | vascular solutions zerusa | GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE | September 7, 2012 |
| K120069 | medline industries | MEDLINE STOPCOCK AND MANIFOLD | April 3, 2012 |
| K113148 | synexmed(shenzhen)company limited | E-PASS | February 28, 2012 |
| K113845 | medtronic | TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE | January 25, 2012 |
| K113132 | coeur | DISPOSABLE HEMOSTATIC Y-CONNECTORS | January 20, 2012 |
| K113667 | edwards lifesciences | CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING | January 12, 2012 |
| K101113 | zerusa limited | GUARDIAN II NC HEMOSTASIS VALVE | May 21, 2010 |
| K093992 | terumo cardiovascular systems corporation | TERUMO LAUER LOCK ADAPTER | May 19, 2010 |
| K100319 | merit medical systems | MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPH | April 28, 2010 |
| K091634 | navilyst medical | NMI FC | March 1, 2010 |
| K092563 | vascular solutions | GATOR CLIPSEAL PLUG | November 4, 2009 |
| K092711 | zerusa limited | GUARDIAN II HEMOSTASIS VALVE | October 1, 2009 |
| K080472 | sedat | SEDAT MYSHELL LITE | April 23, 2008 |
| K073260 | device partners international | LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 | March 13, 2008 |