Disposable Hemostatic Y-Connectors
FDA 510(k) K113132 · Coeur, Inc.
510(k) numberK113132
Submission
- Device name
- Disposable Hemostatic Y-Connectors
- Applicant
- Coeur, Inc.
Lebanon, TN, US - Received
- October 24, 2011
- Decision date
- January 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K152528 | Attachable Cath Lab Hemostasis ValveDTL · Traditional | Galt Medical Corp. | 12/02/2015SE |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…DXT · Traditional | 08/18/2017SE |
| K161471 | MR Syringe Dual Pack for Solaris InjectorsDXT · Traditional | 10/06/2016SE |
| K150902 | 330psi Extension Y-Line with Dual Check ValveDXT · Traditional | 10/22/2015SE |
| K142745 | 125mL CT SyringeDXT · Traditional | 04/01/2015SE |
| K140469 | MR Syringe Dual PackDXT · Traditional | 07/28/2014SE |
| K133600 | Coeur, Inc. Frontload for Optivantage Power InjectorDXT · Traditional | 04/30/2014SE |
| K120892 | Disposable 330PSI Extension LinesDXT · Traditional | 06/10/2013SE |
| K113498 | Disposable Torque DeviceDQX · Traditional | 07/20/2012SE |
| K090487 | Disposable Angiographic Syringes for Use with Nemoto Angiographic Power, Model SY-125…DXT · Traditional | 10/19/2009SE |
| K070798 | Adapters for CT, Angiographic, And/Or MRI Power InjectorsDXT · Traditional | 10/04/2007SE |
Questions and answers
When was Disposable Hemostatic Y-Connectors cleared by the FDA?
Disposable Hemostatic Y-Connectors (K113132) received a 510(k) decision of Substantially Equivalent on January 20, 2012, 88 days after the submission was received.
What is the product code of K113132?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.