VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
FDA 510(k) clearance K103260 · decided 2011-02-18
Clearance details
- K-number
- K103260
- Device name
- VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
- Applicant
- Vasonova, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-04
- Decision date
- 2011-02-18
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- OBJ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.