Cleared Traditional

K203008 - DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

K203008 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 Traditional 510(k) pathway after a 49-day FDA review.

K203008 · Cardiovascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
49d
Days
Class 2
Risk

K203008 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 November 19, 2020 after a review of 49 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 Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K203008

510(k) Number K203008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2020
Decision Date November 19, 2020
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 119
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K203008.
TurboHawk Plus Directional Atherectomy System
K212027 · Medtronic, Inc. · Aug 2021
2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
K211518 · Volcano Atheromed, Inc. · Jun 2021
Auryon Atherectomy System
K202835 · Eximo Medical, Ltd. · Dec 2020
Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
K191419 · Rex Medical, L.P. · Sep 2019
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
K190634 · Cardiovascular Systems, Inc. · Jul 2019
Pantheris SV
K182341 · Avinger, Inc. · Apr 2019