Cleared Traditional

K162561 - Turbo-Power (2.0mm) Laser Atherectomy C...

K162561 is an FDA 510(k) clearance for Turbo-Power (2.0mm) Laser Atherectomy C..., manufactured by Spectranetics, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 113-day FDA review.

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

FDA 510(k) Submission Details - K162561

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.

MCW Device Classification - Class 2, Special Controls

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 76
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K162561.
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K180694 · Spectranetics, Inc. · Apr 2018
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled
K172236 · Avinger, Inc. · Oct 2017
Diamondback 360 Peripheral Orbital Atherectomy System
K170792 · Cardiovascular Systems, Inc. · Jun 2017
Pantheris Catheter (8F)
K163264 · Avinger, Inc. · Dec 2016
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
K162326 · Avinger, Inc. · Oct 2016
Pantheris Catheter
K160827 · Avinger, Inc. · Apr 2016