GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
FDA 510(k) clearance K122301 · decided 2012-09-07
Clearance details
- K-number
- K122301
- Device name
- GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
- Applicant
- Vascular Solutions Zerusa , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-01
- Decision date
- 2012-09-07
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- DTL
- Device class
- 2
- Regulation number
- 870.4290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only availabl recall (Z-1275-2016) | Vascular Solutions, Inc. | 2016-04-07 |
| Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiop recall (Z-0955-2013) | Vascular Solutions, Inc. | 2013-03-20 |