Turbo-Power Laser Atherectomy Catheter
The Turbo-Power Laser Atherectomy Catheter delivers ultraviolet laser energy to obstructing tissue in peripheral arteries. Optical fibres carry energy from a compatible laser console to the…
The Turbo-Power Laser Atherectomy Catheter delivers ultraviolet laser energy to obstructing tissue in peripheral arteries. Optical fibres carry energy from a compatible laser console to the catheter tip, where it breaks down lesion material. The catheter combines this fibre assembly with a motor drive unit.
It is used for new or recurrent lesions in native arteries below the groin and for restenosis within bare nitinol stents in the femoropopliteal arteries, with adjunctive balloon angioplasty. The 2.0 and 2.3 millimetre catheters are used in vessels with reference diameters of at least 3 millimetres.
Compatibility and Placement
The catheter is compatible with the CVX-300 Excimer Laser System and Philips Laser System. It tracks over a 0.018 inch guidewire and has a radiopaque distal marker. Each catheter is supplied sterile for a single prescription use.
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Quasar Electronics Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
Record
| Listed by | Spectranetics Corp., United States |
|---|---|
| FDA product code | MCW |
| Device type | Catheter, Peripheral, Atherectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4875 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K222837 |
| Record published | 2018-11-29 |
| Record revised | 2024-10-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry |
| Sizes | Outer diameter 2 to 2.3 mm; length 125 to 150 cm; lumen/inner diameter 0.018 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 423-050 | Outer Diameter 2.3 mm | In distribution |
| 420-050 | Outer Diameter 2.0 mm | In distribution |
| 423-050 | Outer Diameter 2.3 mm | In distribution |
| 420-050 | Outer Diameter 2.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diamondback Peripheral | Cardiovascular Systems Incorporated | 44 |
| Turbo-Elite™ | Spectranetics Corp. | 24 |
| Stealth | Cardiovascular Systems Incorporated | 20 |
| Zilient | Cardiovascular Systems Incorporated | 16 |
| TurboHawk | Covidien LP | 15 |
| HawkOne | Covidien LP | 14 |
| Turbo-Elite Laser Atherectomy Catheter | Spectranetics Corp. | 12 |
| SilverHawk | Covidien LP | 11 |
| Auryon Atherectomy Catheter | Eximo Medical Ltd | 10 |
| Revolution Peripheral Atherectomy System | Rex Medical | 8 |
| Peripheral RotaLink® Plus | Boston Scientific Corporation | 8 |
| SilverHawkTM | Covidien LP | 8 |
Showing 12 of 102. All products under Catheter, Peripheral, Atherectomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250385 | 2025-03-13 |
| K222837 | 2022-12-08 |
| K180694 | 2018-04-05 |
| K172687 | 2017-11-27 |
| K170059 | 2017-04-07 |
| K162561 | 2017-01-05 |
| K152181 | 2015-11-12 |
| K140775 | 2014-07-23 |
| K123632 | 2013-01-25 |
| K094036 | 2010-01-25 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-11-25 | Class II | Device Design | Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted. | 40,276 catheters | |
| 2023-11-15 | Class II | Packaging process control | Incorrect product labeling. Exterior product box label does not match internal pouch label. | 1,239 catheters | |
| 2017-06-06 | Class II | Device Design | Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner. | 2021-07-08 | |
| 2016-10-31 | Class II | Packaging | Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging. | 14,624 units | 2017-04-18 |
| 2016-01-15 | Class II | Error in labeling | The product is labeled with an expiration date that is past its shelf life. | 8 units | 2017-03-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.