GUARDIAN II NC HEMOSTASIS VALVE
FDA 510(k) clearance K101113 · decided 2010-05-21
Clearance details
- K-number
- K101113
- Device name
- GUARDIAN II NC HEMOSTASIS VALVE
- Applicant
- Zerusa Limited
- Decision
- Substantially Equivalent
- Date received
- 2010-04-21
- Decision date
- 2010-05-21
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DTL
- Device class
- 2
- Regulation number
- 870.4290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Galway, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiop recall (Z-0955-2013) | Vascular Solutions, Inc. | 2013-03-20 |
| Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. recall (Z-2400-2012) | Vascular Solutions, Inc. | 2012-09-17 |