Cleared Traditional

K161361 - HawkOne Directional Atherectomy System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161361 · Medtronic Vascular, Inc. · Cardiovascular device
Oct 2016
Decision
151d
Days
Class 2
Risk

K161361 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 Medtronic Vascular, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 14, 2016 after a review of 151 days - an extended review cycle.

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.

Submission Details

510(k) Number K161361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2016
Decision Date October 14, 2016
Days to Decision 151 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 140d · This submission: 151d
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 9
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K161361.
FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
K250723 · Cardio Flow Inc., · Apr 2025
Rotarex Atherectomy System
K242757 · Bard Peripheral Vascular, Inc. · Jan 2025
Pantheris LV Atherectomy Catheter
K230005 · Avinger, Inc. · Jun 2023
ROTAPRO Rotational Atherectomy System
K220962 · Boston Scientific Corporation · Sep 2022
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
K220109 · Cardiovascular Systems, Inc. · Mar 2022
Pantheris System
K212047 · Avinger, Inc. · Nov 2021