Cleared Special

Turbo-Elite Laser Atherectomy Catheter

K250385 · Spectranetics · Cardiovascular
Mar 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K250385 is an FDA 510(k) clearance for the Turbo-Elite Laser Atherectomy Catheter, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Spectranetics (Colorado Springs, US). The FDA issued a Cleared decision on March 13, 2025, 30 days after receiving the submission on February 11, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K250385 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2025
Decision Date March 13, 2025
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MCW — Catheter, Peripheral, Atherectomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4875

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