Abiomed Cardiovascular, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Abiomed Cardiovascular, 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 Johnson & Johnson MedTech, based on public ownership records.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSQ | Ventricular (Assist) Bypass | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P900023 | PMA | ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM | 1992-11-20 |
Recalls
openFDA lists no recalls under a recalling firm named Abiomed Cardiovascular, 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.
- Abiomed, Inc. (19 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abiomed Cardiovascular, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Abiomed Cardiovascular, 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 Abiomed Cardiovascular, Inc.?
The most frequent FDA product codes under this applicant name are DSQ (Ventricular (Assist) Bypass, 1).
Next steps
- See all 0 Abiomed Cardiovascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSQ, Abiomed Cardiovascular, 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 (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.