Turbo-Elite Laser Atherectomy Catheter
FDA 510(k) K250385 · Spectranetics
510(k) numberK250385
Submission
- Device name
- Turbo-Elite Laser Atherectomy Catheter
- Applicant
- Spectranetics
Colorado Springs, CO, US - Received
- February 11, 2025
- Decision date
- March 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
Other 510(k)s with product code MCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260244 | Auryon Atherectomy SystemMCW · Traditional | Eximo Medical | 04/10/2026SE |
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…MCW · Special | Cardio Flow Inc., | 04/25/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | Bard Peripheral Vascular, Inc. | 01/30/2025SE |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Special | Cardio Flow Inc., | 11/05/2024SE |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingMCW · Special | Eximo Medical, Ltd. | 06/27/2024SE |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)MCW · Special | Cardio Flow Inc., | 02/15/2024SE |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…MCW · Special | Eximo Medical, Ltd. | 12/15/2023SE |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Traditional | Cardio Flow Inc., | 09/27/2023SE |
| K230709 | Auryon Atherectomy SystemMCW · Special | Eximo Medical, Ltd. | 06/09/2023SE |
| K230005 | Pantheris LV Atherectomy CatheterMCW · Traditional | Avinger, Inc. | 06/06/2023SE |
More from Avinger, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | 12/15/2022SE |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Special | 12/08/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | 08/24/2022SE |
| K203540 | Bridge Occlusion BalloonMJN · Special | 12/23/2020SE |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Special | 04/05/2018SE |
| K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Traditional | 11/27/2017SE |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy CathetersMCW · Traditional | 04/07/2017SE |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy CathetersMCW · Traditional | 01/05/2017SE |
| K161333 | TightRail Sub-C Rotating Dilator SheathDRE · Traditional | 07/08/2016SE |
| K153530 | Bridge Occlusion BalloonMJN · Traditional | 02/05/2016SE |
Questions and answers
When was Turbo-Elite Laser Atherectomy Catheter cleared by the FDA?
Turbo-Elite Laser Atherectomy Catheter (K250385) received a 510(k) decision of Substantially Equivalent on March 13, 2025, 30 days after the submission was received.
What is the product code of K250385?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.