Attachable Cath Lab Hemostasis Valve
FDA 510(k) K152528 · Galt Medical Corp.
510(k) numberK152528
Submission
- Device name
- Attachable Cath Lab Hemostasis Valve
- Applicant
- Galt Medical Corp.
Garland, TX, US - Received
- September 3, 2015
- Decision date
- December 2, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4290
- Specialty
- Cardiovascular
Other 510(k)s with product code DTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143429 | Passage Hemostasis ValveDTL · Special | Merit Medical Systems, Inc. | 12/22/2014SE |
| K140475 | Rotating AdaptersDTL · Traditional | Merit Medical Systems, Inc. | 04/16/2014SE |
| K131124 | ColignDTL · Traditional | Jilin Coronado Medical , Ltd. | 08/28/2013SE |
| K123448 | Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock…DTL · Special | Medtronic, Inc. | 12/13/2012SE |
| K122811 | Connector Components with Balance BiosurfaceDTL · Special | Medtronic, Inc. | 10/12/2012SE |
| K122301 | Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveDTL · Traditional | Vascular Solutions Zerusa , Ltd. | 09/07/2012SE |
| K120069 | Medline Stopcock and ManifoldDTL · Traditional | Medline Industries, Inc. | 04/03/2012SE |
| K113148 | E-PassDTL · Traditional | Synexmed(Shenzhen)Company Limited | 02/28/2012SE |
| K113845 | Tubing, Conmnectors, and Accessories Wit Balance BiosurfaceDTL · Special | Medtronic, Inc. | 01/25/2012SE |
| K113132 | Disposable Hemostatic Y-ConnectorsDTL · Traditional | Coeur, Inc. | 01/20/2012SE |
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| K173287 | Elite HV RadialDYB · Traditional | 12/21/2017SESK |
| K172487 | Coaxial Dilator Set (Micro-Introducer)DRE · Traditional | 10/16/2017SESK |
| K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerDYB · Traditional | 07/05/2016SE |
| K140028 | Galt Vti Low Insertion Valve Tearaway IntroducerDYB · Traditional | 08/21/2014SE |
| K123430 | Microslider Tearaway Introducer SetDYB · Traditional | 04/12/2013SE |
| K112398 | Triv(Tm) Valved Tearaway Introducer, Tirv(Tm) Valved Tearaway Introducer with Side PortDYB · Special | 04/12/2012SE |
| K071330 | Galtstick Introducer SystemDRE · Special | 10/31/2007SE |
| K043525 | Catheter IntroducerDYB · Special | 02/09/2005SE |
Questions and answers
When was Attachable Cath Lab Hemostasis Valve cleared by the FDA?
Attachable Cath Lab Hemostasis Valve (K152528) received a 510(k) decision of Substantially Equivalent on December 2, 2015, 90 days after the submission was received.
What is the product code of K152528?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.