Turbo-Elite Laser Atherectomy Catheter— 510(k) K250385
Substantially EquivalentSpectranetics
FDA 510(k) clearance K250385 for Turbo-Elite Laser Atherectomy Catheter, Substantially Equivalent on 2025-03-13. Applicant: Spectranetics. Device class: 2.
Clearance details
- Applicant
- Spectranetics
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Colorado Springs, CO, US
Recent devices under product code MCW
view all- K260244 — Auryon Atherectomy System
- K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
- K242757 — Rotarex Atherectomy System
- K242947 — FreedomFlow Orbital Circumferential Atherectomy System
- K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
Adverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.