Abbott Vascular (Idef Technologies Inc): FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Abbott Vascular (Idef Technologies Inc)”, plus 1 PMA decision, across 1 product code in 1 review panel. 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.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NIP | Stent, Superficial Femoral Artery | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P120020 | PMA | SUPERA PERIPHERAL STENT SYSTEM | 2014-03-28 |
Recalls
openFDA lists no recalls under a recalling firm named Abbott Vascular (Idef Technologies 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.
- 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 (Idef Technologies Inc)?
FDA lists 0 510(k) clearances under the applicant name “Abbott Vascular (Idef Technologies Inc)”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Abbott Vascular (Idef Technologies Inc)?
The most frequent FDA product codes under this applicant name are NIP (Stent, Superficial Femoral Artery, 1).
Next steps
- See all 0 Abbott Vascular (Idef Technologies Inc) clearances with predicates and recalls
- Run predicate analysis for product code NIP, Abbott Vascular (Idef Technologies 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.