Vascular Control Systems, Inc.: FDA clearances and approvals
Vascular Control Systems, Inc. has 9 FDA 510(k) clearances (first 2002, latest 2006), across 4 product codes in 3 review panels. Median 510(k) review time: 46 days.
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 |
|---|---|---|---|
| DXC | Clamp, Vascular | 4 | 4 |
| HDC | Tenaculum, Uterine | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
Review panels
- Cardiovascular (5)
- Obstetrics and Gynecology (2)
- Radiology (2)
Most recent Vascular Control Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060573 | BURBANK TENACULUM | HDC | 2006-04-21 | 46 |
| K052209 | VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 | DPW | 2005-09-06 | 22 |
| K032125 | CSTAT, MODELS 09-0014-01 AND 09-0014-02 | DXC | 2004-02-09 | 214 |
| K031812 | TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 | DXC | 2003-12-12 | 183 |
| K031358 | TRANSVAGINAL DOPPLER PROBE | ITX | 2003-05-09 | 9 |
| K030078 | BURBANK TENACULUM, MODEL 09-0011-01 | HDC | 2003-01-24 | 15 |
| K023154 | VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 | DXC | 2002-12-20 | 88 |
| K023024 | TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 | ITX | 2002-09-26 | 15 |
| K011863 | VCS-A SERIES CLAMP | DXC | 2002-02-15 | 246 |
Recalls
openFDA lists no recalls under a recalling firm named Vascular Control Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Vascular Control Systems, Inc. have?
Vascular Control Systems, Inc. has 9 FDA 510(k) clearances (first 2002, latest 2006), across 4 product codes in 3 review panels.
How long does FDA take to clear Vascular Control Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vascular Control Systems, Inc.'s cleared 510(k)s is 46 days.
What devices does Vascular Control Systems, Inc. make?
Its most frequent FDA product codes are DXC (Clamp, Vascular, 4); HDC (Tenaculum, Uterine, 2); ITX (Transducer, Ultrasonic, Diagnostic, 2).
Has Vascular Control Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Vascular Control Systems, Inc. Related entities may recall under other names.
Next steps
- See all 9 Vascular Control Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXC, Vascular Control Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.