Abbott Vascular Devices: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Abbott Vascular Devices” (first 2005, latest 2005), plus 2 PMA decisions, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 11 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 | 0 |
| MGB | Device, Hemostasis, Vascular | 1 | 0 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 1 | 1 |
Review panels
Most recent Abbott Vascular Devices 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052454 | THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM | NTE | 2005-09-14 | 8 |
| K050501 | MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM | FGE | 2005-03-14 | 14 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050007 | PMA | STARCLOSE VASCULAR CLOSURE SYSTEM | 2005-12-21 |
| P910031 | PMA | ORACLE(TM) CORONARY BALLOON DILATATION CATHETER | 1994-09-30 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-07-21.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Abbott Vascular Devices (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
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 Devices?
FDA lists 2 510(k) clearances under the applicant name “Abbott Vascular Devices” (first 2005, latest 2005), plus 2 PMA decisions, 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 Devices?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott Vascular Devices is 11 days.
Which FDA product codes appear under Abbott Vascular Devices?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 1); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 1); MGB (Device, Hemostasis, Vascular, 1).
Next steps
- See all 2 Abbott Vascular Devices clearances with predicates and recalls
- Run predicate analysis for product code FGE, Abbott Vascular Devices'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.