Cleared Special

K071427 - DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

K071427 is an FDA 510(k) clearance for DIAMONDBACK 360 DEGREE ORBITAL ATHERECT..., 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 99-day FDA review.

K071427 · Cardiovascular Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2007
Decision
99d
Days
Class 2
Risk

K071427 is an FDA 510(k) clearance for the DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT .... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Cardiovascular Systems, Inc. (Saint Paul, US). The FDA issued a Cleared decision on August 30, 2007 after a review of 99 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K071427

510(k) Number K071427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2007
Decision Date August 30, 2007
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 119
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K071427.
PATHWAY PV ATHERECTOMY SYSTEM
K081328 · Pathway Medical Technologies, Inc. · Jul 2008
MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
K072748 · Cardiovascular Systems, Inc. · Nov 2007
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K072800 · Cardiovascular Systems, Inc. · Oct 2007
THROMCAT THROMBECTOMY CATHETER SYSTEM
K072195 · Kensey Nash Corp. · Aug 2007
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K071350 · Cardiovascular Systems, Inc. · Aug 2007
THROMCAT THROMBECTOMY CATHETER SYSTEM
K060016 · Kensey Nash Corp. · Apr 2006