Cleared Special

K220109 - DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

K220109 is an FDA 510(k) clearance for DIAMONDBACK 360 Peripheral Orbital Athe..., manufactured by Cardiovascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Special 510(k) pathway after a 47-day FDA review.

K220109 · Cardiovascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
47d
Days
Class 2
Risk

K220109 is an FDA 510(k) clearance for the DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Periph.... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Cardiovascular Systems, Inc. (St.Paul, US). The FDA issued a Cleared decision on March 1, 2022 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K220109

510(k) Number K220109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2022
Decision Date March 01, 2022
Days to Decision 47 days
Submission Type Special
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
78d faster than avg
Panel avg: 125d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

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 145
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K220109.
ROTAPRO Rotational Atherectomy System
K220962 · Boston Scientific Corporation · Sep 2022
Auryon Atherectomy System
K221077 · Eximo Medical, Ltd. · Jun 2022
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
K220568 · Cardiovascualr Systems, Inc. · Apr 2022
Revolution Peripheral Atherectomy System
K212351 · Rex Medical, L.P. · Dec 2021
Pantheris System
K212047 · Avinger, Inc. · Nov 2021
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
K210586 · Cardiovascular Systems, Inc. · Sep 2021
K220109 · DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
Download PDF FDA Summary Cardiovascular System…