Cleared Traditional

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K220568) - FDA 510(k) Clearance

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

K220568 · Cardiovascualr Systems, Inc. · Cardiovascular device
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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.

View all Cardiovascualr Systems, Inc. devices

Submission Details

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.

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 44
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