Cleared Traditional

K111723 - TURBOHAWK PERIPHERAL PLAQUE EXCISION SY...

K111723 is the FDA 510(k) clearance for TURBOHAWK PERIPHERAL PLAQUE EXCISION SY... by Ev3, Inc.. It is a Class 2 Cardiovascular device (product code MCW) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K111723 · Ev3, Inc. · Cardiovascular device
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Oct 2011
Decision
129d
Days
Class 2
Risk

K111723 is an FDA 510(k) clearance for the TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Ev3, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 27, 2011 after a review of 129 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 Ev3, Inc. devices

Submission Details

510(k) Number K111723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2011
Decision Date October 27, 2011
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

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. 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
NCT00733135 Completed Interventional Industry-sponsored

Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)

Determination of Safety and Effectiveness of the SilverHawk™ Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX™ Embolic Protection Device for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++)

133
Patients (actual)
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Arterial Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Daniel Clair, MD
Sponsor Medtronic Endovascular (industry)
Started 2008-10-01 → Primary completion 2010-11-01
Primary outcome
Successful Revascularization
Secondary outcome
Technical Procedural Success
View full study on ClinicalTrials.gov

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 52
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K111723.
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JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
K122916 · Medrad, Inc. · Oct 2012
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
K121774 · Boston Scientific Corp · Sep 2012
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
K103618 · Ev3, Inc. · Jan 2011
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K093301 · Ev3, Inc. · Nov 2009
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
K990829 · Arrow Intl., Inc. · May 1999