VasoNova, Inc.
FDA Regulatory Profile
VasoNova, Inc. appears in FDA public data with 1 recall, 8 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1408-2015, Class II) was initiated on March 30, 2015. Its most recent 510(k) clearance was granted on January 18, 2013.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1408-2015 | Class II | VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: Th | March 30, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE | January 18, 2013 |
| K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET | February 18, 2011 |
| K103260 | VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE | February 18, 2011 |
| K091924 | VPS CATHETER | November 18, 2009 |
| K083920 | FLOWPICC CATHETER | May 1, 2009 |
| K082481 | FLOWPICC CATHETER | December 17, 2008 |
| K081626 | FLOWPICC CONSOLE | October 15, 2008 |
| K081625 | FLOWPICC STYLET | September 26, 2008 |