Turbo-Elite Laser Atherectomy Catheter
12 catalogue numbers from 423-135-01, listed by Spectranetics Corp., United States, under Catheter, Peripheral, Atherectomy. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
12catalogue numbers in this listing
10510(k) clearances naming this product code
5recalls on this code
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 |
| Record published | 2016-04-15 |
| Record revised | 2024-07-31 (version 6) |
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 0.97 to 2.6 mm; length 112 to 150 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 423-135-01 | Outer Diameter 2.3 mm | In distribution |
| 410-152 | Outer Diameter 0.97 mm | In distribution |
| 417-156 | Outer Diameter 1.75 mm | In distribution |
| 417-152 | Outer Diameter 1.45 mm | In distribution |
| 420-159 | Outer Diameter 2.0 mm | In distribution |
| 423-001 | Outer Diameter 2.3 mm | In distribution |
| 420-006 | Outer Diameter 2.0 mm | In distribution |
| 425-135-01 | Outer Diameter 2.6 mm | In distribution |
| 425-011 | Outer Diameter 2.6 mm | In distribution |
| 410-154 | Outer Diameter 0.97 mm | In distribution |
| 414-151 | Outer Diameter 1.40 mm | In distribution |
| 414-159 | Outer Diameter 1.45 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 |
| 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 |
| Peripheral Rotapro™ | Boston Scientific Corporation | 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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Spectranetics Corp. | UDI-DI | 2023-11-15 | Class II | Packaging process control | Incorrect product labeling. Exterior product box label does not match internal pouch label. | 1,239 catheters |
Recalls
4 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 | |
| 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.