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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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 145
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K071427.
SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE
K071432 · Fox Hollow Technologies · Feb 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
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K061188 · Foxhollow Technologies, Inc. · Oct 2006
K071427 · DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
Download PDF FDA Summary Cardiovascular System…