Cleared Traditional

K140775 - TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01330628 Completed Interventional Industry-sponsored

Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis

EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis

252
Patients (actual)
34
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Peripheral Arterial Disease
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Eric J Dippel, MD
Sponsor Spectranetics Corporation (industry)
Started 2011-06-01 → Primary completion 2014-03-01 → Completed 2015-05-01
Primary outcome
Freedom From Target Lesion Revascularization (TLR)
View full study on ClinicalTrials.gov

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 142
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K140775.
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · Covidien, LLC · Oct 2014
JETSTREAM XC 2.4/3.4
K133023 · Medrad, Inc. · Aug 2014
1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
K140944 · Atheromed, Inc. · Aug 2014
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133999 · Cardiovascular Systems, Inc. · Feb 2014
PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA
K132682 · Atheromed, Inc. · Jan 2014
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
K133566 · Boston Scientific Corp · Dec 2013
K140775 · TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
Download PDF FDA Summary Spectranetics Corpora…