Spectranetics (Philips): FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Spectranetics (Philips)”, 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 |
|---|---|---|---|
| MFA | Device, Removal, Pacemaker Electrode, Percutaneous | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P960042 | PMA | SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH | 1997-12-09 |
Recalls
openFDA lists no recalls under a recalling firm named Spectranetics (Philips).
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.
- Spectranetics Corp. (43 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spectranetics (Philips)?
FDA lists 0 510(k) clearances under the applicant name “Spectranetics (Philips)”, 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 Spectranetics (Philips)?
The most frequent FDA product codes under this applicant name are MFA (Device, Removal, Pacemaker Electrode, Percutaneous, 1).
Next steps
- See all 0 Spectranetics (Philips) clearances with predicates and recalls
- Run predicate analysis for product code MFA, Spectranetics (Philips)'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.