Cleared Traditional

K220568 - Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

K220568 is an FDA 510(k) clearance for Diamondback 360 Peripheral Orbital Athe..., manufactured by Cardiovascualr Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K220568 · Cardiovascualr Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
58d
Days
Class 2
Risk

K220568 is an FDA 510(k) clearance for the Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral.... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Cardiovascualr Systems, Inc. (St.Paul, US). The FDA issued a Cleared decision on April 27, 2022 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K220568

510(k) Number K220568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2022
Decision Date April 27, 2022
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 142
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K220568.
Auryon Atherectomy Catheters
K220116 · Eximo Medical, Ltd. · Sep 2022
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, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
K220109 · Cardiovascular Systems, Inc. · Mar 2022
Revolution Peripheral Atherectomy System
K212351 · Rex Medical, L.P. · Dec 2021
Pantheris System
K212047 · Avinger, Inc. · Nov 2021
K220568 · Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
Download PDF FDA Summary Cardiovascualr System…