Cleared Special

K152694 - Diamondback 360 Peripheral Orbital Atherectomy System

K152694 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 30-day FDA review.

K152694 · Cardiovascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
30d
Days
Class 2
Risk

K152694 is an FDA 510(k) clearance for the Diamondback 360 Peripheral Orbital Atherectomy System. 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 October 21, 2015 after a review of 30 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 - K152694

510(k) Number K152694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2015
Decision Date October 21, 2015
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 142
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K152694.
Pantheris Catheter
K160827 · Avinger, Inc. · Apr 2016
Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
K153460 · Avinger, Inc. · Mar 2016
Turbo-Power Laser Atherectomy Catheter
K152181 · Spectranetics, Inc. · Nov 2015
Pantheris System
K152275 · Avinger, Inc. · Oct 2015
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
K151260 · Cardiovascular System, Inc. · Jun 2015
2.4mm X 127 cm Phoenix Atherectomy Deflecting System
K151145 · Volcano Atheromed, Inc. · May 2015
K152694 · Diamondback 360 Peripheral Orbital Atherectomy System
Download PDF FDA Summary Cardiovascular System…