Cleared Traditional

Turbo-Power (2.0mm) Laser Atherectomy Catheters (K162561) - FDA 510(k) Clearance

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

K162561 · Spectranetics, Inc. · Cardiovascular device
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Jan 2017
Decision
113d
Days
Class 2
Risk

K162561 is an FDA 510(k) clearance for the Turbo-Power (2.0mm) Laser Atherectomy Catheters. 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 January 5, 2017 after a review of 113 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 K162561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2016
Decision Date January 05, 2017
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 K162561.
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