Cleared Traditional

K140775 - TURBO-ELITE ATHERECTOMY CATHETERS

K140775 is an FDA 510(k) clearance for TURBO-ELITE ATHERECTOMY CATHETERS, manufactured by Spectranetics Corporation. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K140775 · Spectranetics Corporation · Cardiovascular device
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Jul 2014
Decision
117d
Days
Class 2
Risk

K140775 is an FDA 510(k) clearance for the TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Spectranetics Corporation (Colorado Springs, US). The FDA issued a Cleared decision on July 23, 2014 after a review of 117 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 Corporation devices

FDA 510(k) Submission Details - K140775

510(k) Number K140775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2014
Decision Date July 23, 2014
Days to Decision 117 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
8d faster than avg
Panel avg: 125d · This submission: 117d
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 81
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K140775.
Diamondback 360 Peripheral Orbital Atherectomy System
K150732 · Cardiovascular Systems, Inc. · Apr 2015
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · Covidien, LLC · Oct 2014
JETSTREAM XC 2.4/3.4
K133023 · Medrad, Inc. · Aug 2014
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133999 · Cardiovascular Systems, Inc. · Feb 2014
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
K133566 · Boston Scientific Corp · Dec 2013
JETSTREAM XC 2.4/3.4 SYSTEM
K130637 · Medrad, Inc. · Apr 2013