Spectranetics Corp.: FDA filings under this applicant name

FDA lists 43 510(k) clearances under the applicant name “Spectranetics Corp.” (first 1999, latest 2025), plus 3 PMA and 1 De Novo decisions, across 10 product codes in 1 review panel. Median 510(k) review time under this name: 79 days. Since 2017 the median was 79 days, against 102 days for all cleared 510(k)s in the same product codes. 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.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Spectranetics Corp. took a median 79 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.

Top product codes

Review panels

• Cardiovascular (47)

Most recent Spectranetics Corp. 510(k) clearances

33 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

21 product recalls in 18 recall events; 5 initiated in the last five years. Most recent: 2025-01-10.

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.

Device clinical trials

An industry sponsor named Spectranetics Corp. is the lead sponsor of 15 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT03306199: TurboPower + DCB Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions (Completed, started 2017-10-03)
• NCT03284229: Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD (Completed, started 2017-09-20)
• NCT03268018: ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study (Completed, started 2017-06-07)
• NCT02921542: An Evaluation of a Clinical Algorithm With Turbo-Power Following Treatment of Specific Morphologies (Completed, started 2016-08-15)
• NCT02769273: Stellarex Vascular E-Registry (Completed, started 2016-06)

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 (Philips) (0 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Spectranetics Corp.?

FDA lists 43 510(k) clearances under the applicant name “Spectranetics Corp.” (first 1999, latest 2025), plus 3 PMA and 1 De Novo decisions, across 10 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Spectranetics Corp.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Spectranetics Corp. is 79 days. Since 2017: 79 days, versus 102 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Spectranetics Corp.?

The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 11); MCW (Catheter, Peripheral, Atherectomy, 10); DRE (Dilator, Vessel, For Percutaneous Catheterization, 9).

Next steps

• See all 43 Spectranetics Corp. clearances with predicates and recalls
• Run predicate analysis for product code DQY, 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.

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