DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4290 · Class 2
Overview
| Product Code | DTL |
|---|---|
| Device Name | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4290 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (20 of 137)
Showing 20 most recent of 137 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152528 | Attachable Cath Lab Hemostasis Valve | Galt Medical Corp. | Dec 2, 2015 | SESE |
| K143429 | Passage Hemostasis Valve | Merit Medical Systems, Inc. | Dec 22, 2014 | SESE |
| K140475 | ROTATING ADAPTERS | Merit Medical Systems, Inc. | Apr 16, 2014 | SESE |
| K131124 | COLIGN | Jilin Coronado Medical , Ltd. | Aug 28, 2013 | SESE |
| K123448 | AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE | Medtronic, Inc. | Dec 13, 2012 | SESE |
| K122811 | CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE | Medtronic, Inc. | Oct 12, 2012 | SESE |
| K122301 | GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE | Vascular Solutions Zerusa , Ltd. | Sep 7, 2012 | SESE |
| K120069 | MEDLINE STOPCOCK AND MANIFOLD | Medline Industries, Inc. | Apr 3, 2012 | SESE |
| K113148 | E-PASS | Synexmed(Shenzhen)Company Limited | Feb 28, 2012 | SESE |
| K113845 | TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE | Medtronic, Inc. | Jan 25, 2012 | SESE |
| K113132 | DISPOSABLE HEMOSTATIC Y-CONNECTORS | Coeur, Inc. | Jan 20, 2012 | SESE |
| K113667 | CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING | Edwards Lifesciences, LLC | Jan 12, 2012 | SESE |
| K101113 | GUARDIAN II NC HEMOSTASIS VALVE | Zerusa Limited | May 21, 2010 | SESE |
| K093992 | TERUMO LAUER LOCK ADAPTER | Terumo Cardiovascular Systems Corporation | May 19, 2010 | SESE |
| K100319 | MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L | Merit Medical Systems, Inc. | Apr 28, 2010 | SESE |
| K091634 | NMI FC | Navilyst Medical, Inc. | Mar 1, 2010 | SESE |
| K092563 | GATOR CLIPSEAL PLUG | Vascular Solutions, Inc. | Nov 4, 2009 | SESE |
| K092711 | GUARDIAN II HEMOSTASIS VALVE | Zerusa Limited | Oct 1, 2009 | SESE |
| K080472 | SEDAT MYSHELL LITE | Sedat | Apr 23, 2008 | SESE |
| K073260 | LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 | Device Partners International | Mar 13, 2008 | SESE |
Top Applicants
- Merit Medical Systems, Inc. — 9 clearances
- Dlp, Inc. — 5 clearances
- North American Instrument Corp. — 5 clearances
- Texas Medical Products, Inc. — 5 clearances
- Advance Medical Designs, Inc. — 4 clearances
