Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve
FDA 510(k) K122301 · Vascular Solutions Zerusa , Ltd.
510(k) numberK122301
Submission
- Device name
- Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve
- Applicant
- Vascular Solutions Zerusa , Ltd.
Minneapolis, MN, US - Received
- August 1, 2012
- Decision date
- September 7, 2012
- 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 |
|---|---|---|---|
| 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 |
| 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 |
Questions and answers
When was Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve cleared by the FDA?
Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve (K122301) received a 510(k) decision of Substantially Equivalent on September 7, 2012, 37 days after the submission was received.
What is the product code of K122301?
The FDA product code is DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4290.