Cleared Traditional

K141801 - HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM

K141801 is the FDA 510(k) clearance for HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM by Covidien, LLC. It is a Class 2 Cardiovascular device (product code MCW) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K141801 · Covidien, LLC · Cardiovascular device
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Oct 2014
Decision
105d
Days
Class 2
Risk

K141801 is an FDA 510(k) clearance for the HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Covidien, LLC (Plymouth, US). The FDA issued a Cleared decision on October 16, 2014 after a review of 105 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 Covidien, LLC devices

Submission Details

510(k) Number K141801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2014
Decision Date October 16, 2014
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
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 47
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K141801.
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
JETSTREAM XC 2.4/3.4
K133023 · Medrad, Inc. · Aug 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