Cleared Traditional

K071350 - DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM

K071350 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 Traditional 510(k) pathway after a 100-day FDA review.

K071350 · Cardiovascular Systems, Inc. · Cardiovascular device
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Aug 2007
Decision
100d
Days
Class 2
Risk

K071350 is an FDA 510(k) clearance for the DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM. 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 22, 2007 after a review of 100 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K071350

510(k) Number K071350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2007
Decision Date August 22, 2007
Days to Decision 100 days
Submission Type Traditional
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
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K071350.
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K072800 · Cardiovascular Systems, Inc. · Oct 2007
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
K071427 · Cardiovascular Systems, Inc. · Aug 2007
THROMCAT THROMBECTOMY CATHETER SYSTEM
K072195 · Kensey Nash Corp. · Aug 2007
THROMCAT THROMBECTOMY CATHETER SYSTEM
K060016 · Kensey Nash Corp. · Apr 2006
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300
K043553 · Fox Hollow Technologies · Feb 2005
ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
K041630 · Cardiovascular Systems Incorporated · Jan 2005