Cleared Traditional

K153460 - Pantheris Catheter (8Fr)

K153460 is the FDA 510(k) clearance for Pantheris Catheter (8Fr) by Avinger, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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
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.

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 K153460.
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
K180416 · Cardiovascular Systems, Inc. · Apr 2018
Straub Endovascular System
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Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K180694 · Spectranetics, Inc. · Apr 2018
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · Covidien, LLC · Oct 2014
JETSTREAM XC 2.4/3.4
K133023 · Medrad, Inc. · Aug 2014
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
K133566 · Boston Scientific Corp · Dec 2013