Turbo-Power (2.0mm) Laser Atherectomy Catheter, Turbo-Power (2.3mm) Laser Atherectomy Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222837 FDA 510(k)
- FDA Product Code
- MCW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4875 FDA 510(k)
- Regulation Number
- 870.4875 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Turbo-Power Laser Atherectomy Catheter is a peripheral atherectomy catheter designed for use in cardiovascular procedures. It is a laser-based device intended for the removal of plaque from peripheral blood vessels.
The device is supplied as a sterile, single-use catheter and is classified as a Class II medical device under FDA regulation 870.4875. It received FDA 510(k) clearance (K222837) as substantially equivalent to a predicate device, with special clearance type and cardiovascular advisory committee review.
Frequently asked questions
What is the Turbo-Power Laser Atherectomy Catheter used for?
The Turbo-Power Laser Atherectomy Catheter is designed for use in cardiovascular procedures to remove plaque from peripheral blood vessels using laser-based atherectomy technology.
How is the Turbo-Power Laser Atherectomy Catheter supplied and is it reusable?
The device is supplied as a sterile, single-use catheter, meaning it is intended for one procedure only and must be discarded after use to prevent cross-contamination and ensure patient safety.
What sizes are available for the Turbo-Power Laser Atherectomy Catheter?
The Turbo-Power Laser Atherectomy Catheter is available in two sizes: 2.0mm and 2.3mm, as indicated in the device name, allowing clinicians to select the appropriate diameter based on vessel size and lesion characteristics.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222837 | Class II | Active |
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Manufacturer
- Manufacturer
- Spectranetics, Inc.
Sources (1)
- FDA 510(k) K222837 24 fields · synced Sep 23, 2026