Cleared Traditional

K182397 - Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

K182397 is an FDA 510(k) clearance for Diamondback 360 Peripheral Orbital Athe..., 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.

K182397 · Cardiovascular Systems, Inc. · Cardiovascular device
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Dec 2018
Decision
100d
Days
Class 2
Risk

K182397 is an FDA 510(k) clearance for the Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Cardiovascular Systems, Inc. (St.Paul, US). The FDA issued a Cleared decision on December 13, 2018 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 - K182397

510(k) Number K182397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2018
Decision Date December 13, 2018
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 K182397.
Pantheris SV
K182341 · Avinger, Inc. · Apr 2019
Phoenix Atherectomy System
K182972 · Volcano Atheromed, Inc. · Dec 2018
Phoenix 2.4mm Atherectomy Plus System
K181877 · Volcano Atheromed, Inc. · Dec 2018
B-Laser Atherectomy System
K181642 · Eximo Medical, Ltd. · Oct 2018
Pantheris System
K173862 · Avinger, Inc. · May 2018
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
K180416 · Cardiovascular Systems, Inc. · Apr 2018