Cleared Traditional

K190634 - Diamondback 360 Peripheral Orbital Athe...

K190634 is the FDA 510(k) clearance for Diamondback 360 Peripheral Orbital Athe... by Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code MCW) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K190634 · Cardiovascular Systems, Inc. · Cardiovascular device
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Jul 2019
Decision
112d
Days
Class 2
Risk

K190634 is an FDA 510(k) clearance for the Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral.... 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 July 2, 2019 after a review of 112 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 K190634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2019
Decision Date July 02, 2019
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
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 52
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K190634.
Auryon Atherectomy System
K202835 · Eximo Medical, Ltd. · Dec 2020
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
K203008 · Cardiovascular Systems, Inc. · Nov 2020
Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
K191419 · Rex Medical, L.P. · Sep 2019
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