Cleared Traditional

K071350 - DIAMONDBACK 360 DEGREE ORBITAL ATHERECT...

K071350 is the FDA 510(k) clearance for DIAMONDBACK 360 DEGREE ORBITAL ATHERECT... by Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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
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.

Device Classification

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 53
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K071350.
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
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TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K093301 · Ev3, Inc. · Nov 2009
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
K990829 · Arrow Intl., Inc. · May 1999
OASIS THROMBECTOMY CATHETER SYSTEM
K982363 · Boston Scientific Corp · Feb 1999
THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)
K973669 · Micro Therapeutics, Inc. · Feb 1998