FDA applicant
Spectranetics Corp.
FDA records 48 decisions for Spectranetics Corp. (Colorado Springs, CO) from 1992 to 2025: 43 510(k) clearances, 1 De Novo grant and 4 original PMA approvals. Most are in product codes DQY (Catheter, Percutaneous) and MCW (Catheter, Peripheral, Atherectomy). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 67 predicates, 51 of them its own earlier devices. 15 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Spectranetics, Inc.”, “Spectranetics Corporation”, “Spectranetics”, “The Spectranetics Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Spectranetics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Spectranetics Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Spectranetics”
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