Cleared Traditional

K153460 - Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)

K153460 is an FDA 510(k) clearance for Pantheris Catheter (8Fr), manufactured by Avinger, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K153460 · Avinger, Inc. · Cardiovascular device
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Mar 2016
Decision
91d
Days
Class 2
Risk

K153460 is an FDA 510(k) clearance for the Pantheris Catheter (8Fr), Pantheris Catheter (7Fr). Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on March 1, 2016 after a review of 91 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 Avinger, Inc. devices

FDA 510(k) Submission Details - K153460

510(k) Number K153460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2015
Decision Date March 01, 2016
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 K153460.
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
K162326 · Avinger, Inc. · Oct 2016
HawkOne Directional Atherectomy System
K161361 · Medtronic Vascular, Inc. · Oct 2016
Pantheris Catheter
K160827 · Avinger, Inc. · Apr 2016
Turbo-Power Laser Atherectomy Catheter
K152181 · Spectranetics, Inc. · Nov 2015
Diamondback 360 Peripheral Orbital Atherectomy System
K152694 · Cardiovascular Systems, Inc. · Oct 2015
Pantheris System
K152275 · Avinger, Inc. · Oct 2015