Vas-Cath, Inc.: FDA clearances and approvals
Vas-Cath, Inc. has 27 FDA 510(k) clearances (first 1988, latest 1998), across 8 product codes in 3 review panels. Median 510(k) review time: 111 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 14 | 14 |
| LFJ | Catheter, Subclavian | 5 | 5 |
| FAD | Stent, Ureteral | 2 | 2 |
| LFK | Catheter, Femoral | 2 | 2 |
| FKA | Dilator, Vessel | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 1 | 1 |
Review panels
Most recent Vas-Cath, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973013 | OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER | LIT | 1998-06-19 | 310 |
| K965178 | NIAGARA DUAL LUMEN CATHETER | MPB | 1997-08-19 | 238 |
| K964881 | ULTRAVERSE PTA CATHETER | LIT | 1997-05-28 | 174 |
| K970725 | OPTI-PLAST XL 5.5 F PTA CATHETER | LIT | 1997-05-09 | 70 |
| K941706 | OPTI-PLAST ANGIOPLASTY CATHETER | LIT | 1994-10-18 | 195 |
| K925485 | VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER | LIT | 1994-03-10 | 496 |
| K933483 | OPTI-PLAST 5F PTA CATHETERS | LIT | 1993-09-24 | 86 |
| K914210 | VAS-CATH DUALATOR(TM) VESSEL DILATOR | FKA | 1993-07-01 | 651 |
| K914162 | VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS | LFJ | 1993-07-01 | 653 |
| K914976 | OPTI-PLAST 5F PTA CATHETERS, MODIFICATION | LIT | 1992-01-27 | 82 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vas-Cath, 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 Vas-Cath, Inc. have?
Vas-Cath, Inc. has 27 FDA 510(k) clearances (first 1988, latest 1998), across 8 product codes in 3 review panels.
How long does FDA take to clear Vas-Cath, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vas-Cath, Inc.'s cleared 510(k)s is 111 days.
What devices does Vas-Cath, Inc. make?
Its most frequent FDA product codes are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 14); LFJ (Catheter, Subclavian, 5); FAD (Stent, Ureteral, 2).
Has Vas-Cath, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Vas-Cath, Inc. Related entities may recall under other names.
Next steps
- See all 27 Vas-Cath, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LIT, Vas-Cath, 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.