The Spectranetics Corp.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “The Spectranetics Corp.”, 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 Philips, based on public ownership records.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160049 | PMA | STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON | 2017-07-26 |
Recalls
openFDA lists no recalls under a recalling firm named The Spectranetics Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Spectranetics Corp.?
FDA lists 0 510(k) clearances under the applicant name “The Spectranetics Corp.”, 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 The Spectranetics Corp.?
The most frequent FDA product codes under this applicant name are ONU (Drug-Eluting Peripheral Transluminal Angioplasty Catheter, 1).
Next steps
- See all 0 The Spectranetics Corp. clearances with predicates and recalls
- Run predicate analysis for product code ONU, The Spectranetics Corp.'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.