Cleared Special

K170792 - Diamondback 360 Peripheral Orbital Atherectomy System

K170792 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 85-day FDA review.

K170792 · Cardiovascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Jun 2017
Decision
85d
Days
Class 2
Risk

K170792 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 June 9, 2017 after a review of 85 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.

View all Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K170792

510(k) Number K170792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2017
Decision Date June 09, 2017
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 100
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K170792.
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K180694 · Spectranetics, Inc. · Apr 2018
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K172687 · Spectranetics, Inc. · Nov 2017
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled
K172236 · Avinger, Inc. · Oct 2017
Spectranetics Turbo-Elite Laser Atherectomy Catheters
K170059 · Spectranetics, Inc. · Apr 2017
Turbo-Power (2.0mm) Laser Atherectomy Catheters
K162561 · Spectranetics, Inc. · Jan 2017
Pantheris Catheter (8F)
K163264 · Avinger, Inc. · Dec 2016