510(k) K123813 ยท OBJ Catheter, Ultrasound, Intravascular
VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE
| Applicant | Vasonova, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Jan 18, 2013 |
| Received | Dec 11, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123813
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2015 | VasoNova, Inc. VasoNova Vascular Positioning System (VPS ) G4 Console
Catalog number VPS-G4C
Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. Terminated |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.