Cleared Special

K133399 - DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

K133399 is an FDA 510(k) clearance for DIAMONDBACK 360 PERIPHERAL ORBITAL ATHE..., manufactured by Cardiovascular Systems Incorporated. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Special 510(k) pathway after a 16-day FDA review.

K133399 · Cardiovascular Systems Incorporated · Cardiovascular device
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Nov 2013
Decision
16d
Days
Class 2
Risk

K133399 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 Incorporated (Saint Paul, US). The FDA issued a Cleared decision on November 22, 2013 after a review of 16 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 Incorporated devices

FDA 510(k) Submission Details - K133399

510(k) Number K133399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2013
Decision Date November 22, 2013
Days to Decision 16 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
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 85
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K133399.
JETSTREAM XC 2.4/3.4
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