Cleared Traditional

Turbo-Power Laser Atherectomy Catheter (K152181) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152181 · Spectranetics, Inc. · Cardiovascular device
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Nov 2015
Decision
100d
Days
Class 2
Risk

K152181 is an FDA 510(k) clearance for the Turbo-Power Laser Atherectomy Catheter. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on November 12, 2015 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectranetics, Inc. devices

Submission Details

510(k) Number K152181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2015
Decision Date November 12, 2015
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 40
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K152181.
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
K180416 · Cardiovascular Systems, Inc. · Apr 2018
Straub Endovascular System
K172315 · Straub Medical AG · Apr 2018
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K180694 · Spectranetics, Inc. · Apr 2018
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
K133566 · Boston Scientific Corp · Dec 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
K121774 · Boston Scientific Corp · Sep 2012
OASIS THROMBECTOMY CATHETER SYSTEM
K982363 · Boston Scientific Corp · Feb 1999