VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE
FDA 510(k) clearance K123813 · decided 2013-01-18
Clearance details
- K-number
- K123813
- Device name
- VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE
- Applicant
- Vasonova, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-11
- Decision date
- 2013-01-18
- Days to decision
- 38 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Vasonova
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascul recall (Z-1408-2015) | VasoNova, Inc. | 2015-04-09 |