Vasonova, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Vasonova, Inc.” (first 2008, latest 2013), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 110 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 38 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBJ | Catheter, Ultrasound, Intravascular | 5 | 5 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 3 | 3 |
Review panels
- Cardiovascular (5)
- General Hospital (3)
Most recent Vasonova, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE | OBJ | 2013-01-18 | 38 |
| K103260 | VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE | OBJ | 2011-02-18 | 106 |
| K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET | OBJ | 2011-02-18 | 107 |
| K091924 | VPS CATHETER | LJS | 2009-11-18 | 141 |
| K083920 | FLOWPICC CATHETER | LJS | 2009-05-01 | 121 |
| K082481 | FLOWPICC CATHETER | LJS | 2008-12-17 | 111 |
| K081626 | FLOWPICC CONSOLE | OBJ | 2008-10-15 | 127 |
| K081625 | FLOWPICC STYLET | OBJ | 2008-09-26 | 108 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-03-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Vasonova, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01232933: Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy (Completed, started 2010-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vasonova, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Vasonova, Inc.” (first 2008, latest 2013), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vasonova, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vasonova, Inc. is 110 days.
Which FDA product codes appear under Vasonova, Inc.?
The most frequent FDA product codes under this applicant name are OBJ (Catheter, Ultrasound, Intravascular, 5); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 3).
Next steps
- See all 8 Vasonova, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OBJ, Vasonova, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.