Abbott Vascular-Vascular Solutions: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Abbott Vascular-Vascular Solutions” (first 2008, latest 2009), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
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 | 2 | 2 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
Review panels
Most recent Abbott Vascular-Vascular Solutions 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090665 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19 | NTE | 2009-05-22 | 70 |
| K090509 | FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER | DQY | 2009-03-20 | 22 |
| K081523 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | NTE | 2008-09-11 | 101 |
| K072708 | ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM | FGE | 2008-08-18 | 328 |
| K080264 | MODIFICATION TO: FOX PLUS PTA CATHETER | LIT | 2008-03-26 | 54 |
| K072798 | VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER | LIT | 2008-01-31 | 122 |
Recalls
openFDA lists no recalls under a recalling firm named Abbott Vascular-Vascular Solutions.
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.
- Abbott Laboratories (889 510(k)s)
- ABBOTT MEDICAL (60 510(k)s)
- Abbott Vascular (50 510(k)s)
- Abbott Diabetes Care, Inc. (39 510(k)s)
- Abbott Diagnostics (28 510(k)s)
- Abbott Point of Care, Inc. (22 510(k)s)
- Abbott Molecular, Inc. (18 510(k)s)
- Abbott Mfg., Inc. (14 510(k)s)
- Abbott Medical Optics, Inc. (13 510(k)s)
- Abbott (13 510(k)s)
- Abbott Spine, Inc. (13 510(k)s)
- Abbott Ireland Diagnostics Division (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott Vascular-Vascular Solutions?
FDA lists 6 510(k) clearances under the applicant name “Abbott Vascular-Vascular Solutions” (first 2008, latest 2009), across 4 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 Abbott Vascular-Vascular Solutions?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott Vascular-Vascular Solutions is 86 days.
Which FDA product codes appear under Abbott Vascular-Vascular Solutions?
The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 2); NTE (Temporary Carotid Catheter For Embolic Capture, 2); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 6 Abbott Vascular-Vascular Solutions clearances with predicates and recalls
- Run predicate analysis for product code LIT, Abbott Vascular-Vascular Solutions'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.