Cleared Traditional

K152275 - Pantheris System

K152275 is an FDA 510(k) clearance for Pantheris System, 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 63-day FDA review.

K152275 · Avinger, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
63d
Days
Class 2
Risk

K152275 is an FDA 510(k) clearance for the Pantheris System. 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 October 14, 2015 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avinger, Inc. devices

FDA 510(k) Submission Details - K152275

510(k) Number K152275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2015
Decision Date October 14, 2015
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01937351 Completed Interventional Industry-sponsored

Evaluation of the Pantheris Atherectomy System

Evaluation of the Pantheris Optical Coherence Tomography Imaging Atherectomy System for Use in the Peripheral Vasculature

162
Patients (actual)
21
Sites
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Arterial Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Gray Bennett, MD
Sponsor Avinger, Inc. (industry)
Started 2013-06-25 → Primary completion 2015-07-15 → Completed 2015-09-20
Primary outcome
Primary Safety Endpoint
Secondary outcome
Secondary Safety Endpoint
View full study on ClinicalTrials.gov

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 K152275.
Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
K153460 · Avinger, Inc. · Mar 2016
Turbo-Power Laser Atherectomy Catheter
K152181 · Spectranetics, Inc. · Nov 2015
Diamondback 360 Peripheral Orbital Atherectomy System
K152694 · Cardiovascular Systems, Inc. · Oct 2015
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
K151260 · Cardiovascular System, Inc. · Jun 2015
2.4mm X 127 cm Phoenix Atherectomy Deflecting System
K151145 · Volcano Atheromed, Inc. · May 2015
Diamondback 360 Peripheral Orbital Atherectomy System
K150732 · Cardiovascular Systems, Inc. · Apr 2015