Devices For Vascular Intervention, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Devices For Vascular Intervention, Inc.” (first 1987, latest 1994), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 76 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 | 0 | — |
| 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 5 | 5 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| DYB | Introducer, Catheter | 2 | 2 |
| MCW | Catheter, Peripheral, Atherectomy | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| MAV | Syringe, Balloon Inflation | 1 | 1 |
Review panels
- Cardiovascular (14)
Most recent Devices For Vascular Intervention, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935929 | MICROTRACK | MCW | 1994-03-10 | 87 |
| K920707 | HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER | MCW | 1992-11-23 | 279 |
| K914422 | DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE | DQY | 1991-12-18 | 76 |
| K911678 | ROTATING HEMOSTATIC VALVE | DYB | 1991-07-12 | 88 |
| K910205 | LP-60 LOW PRESSURE INFLATION DEVICE | MAV | 1991-02-25 | 40 |
| K901601 | HOLLOW MOTOR DRIVE UNIT | LIT | 1990-07-06 | 91 |
| K883933 | INTRODUCING CATHETER | DYB | 1988-12-02 | 78 |
| K883981 | GUIDING CATHETER (TIP SOFTNESS CHANGE) | DWF | 1988-11-03 | 43 |
| K883916 | ROTATING HEMOSTATIC VALVE | DQY | 1988-10-28 | 42 |
| K883346 | SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F | LIT | 1988-09-26 | 60 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Devices For Vascular Intervention, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Devices and Diagnostics Consulting Group (1 510(k)s)
- Devices & Services Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Devices For Vascular Intervention, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Devices For Vascular Intervention, Inc.” (first 1987, latest 1994), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Devices For Vascular Intervention, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Devices For Vascular Intervention, Inc. is 76 days.
Which FDA product codes appear under Devices For Vascular Intervention, Inc.?
The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 5); DQY (Catheter, Percutaneous, 2); DYB (Introducer, Catheter, 2).
Next steps
- See all 14 Devices For Vascular Intervention, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LIT, Devices For Vascular Intervention, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.