Identifiers
- 510(k) Number
- K112032 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a laser atherectomy catheter system consisting of a laser catheter constrained within a guiding catheter. The guiding catheter features an angled biasing tip to offset the laser catheter from the vessel lumen center for circumferential positioning. The laser catheter uses multiple optical fibers around a 0.014-inch guidewire lumen and connects to the Spectranetics CVX-300 Excimer Laser System via an optical coupler.
The system is supplied in vitro and in vivo testing, along with the device's design and intended use, support its substantial equivalence to the predicate device, the Spectranetics 7Fr Turbo-Tandem System (K094036). The 8Fr Turbo-Tandem System is similar in design to the predicate, with the primary change being the size of the biasing tip increased from 7Fr to 8Fr. The instructions for use have been updated to include both 7Fr and 8Fr models. The device is authorized under FDA 510(k) clearance K112032.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 8FR TURBO - TANDEM SYSTEM (K112032) — FDA 510(k) | Innolitics, PDF ep 510(k) Summ - accessdata.fda.gov, 8FR TURBO - TANDEM SYSTEM 510(k) K112032 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112032 | Class II | Active |
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Manufacturer
- Manufacturer
- Spectranetics Corp.
Sources (1)
- FDA 510(k) K112032 24 fields · synced Sep 25, 2026