Cleared Traditional

K170349 - RA-308 Excimer Laser System, Excimer Laser Catheter

K170349 is an FDA 510(k) clearance for RA-308 Excimer Laser System, manufactured by Ra Medical Systems,Inc. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K170349 · Ra Medical Systems,Inc · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
110d
Days
Class 2
Risk

K170349 is an FDA 510(k) clearance for the RA-308 Excimer Laser System, Excimer Laser Catheter. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Ra Medical Systems,Inc (Carlsbad, US). The FDA issued a Cleared decision on May 24, 2017 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Ra Medical Systems,Inc devices

FDA 510(k) Submission Details - K170349

510(k) Number K170349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2017
Decision Date May 24, 2017
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

PDU Device Classification - Class 2, Special Controls

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.
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
NCT02653456 Completed Interventional Industry-sponsored

Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease

A Prospective, Multi Center Pilot Study Evaluating Plaque Photoablation Using the RA-308 Excimer Laser in Subjects With Symptomatic Infrainguinal Lower Extremity Vascular Disease

64
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Arterial Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Ehtisham Mahmud
Sponsor Ra Medical Systems (industry)
Started 2016-04-07 → Primary completion 2017-05-03 → Completed 2017-07-14
Primary outcome
Crossing the Target Lesion
Secondary outcome
Number of Participants With no Device-related Major Adverse Events
View full study on ClinicalTrials.gov

Regulatory Peers - PDU Catheter For Crossing Total Occlusions

All 56
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K170349.
Tigereye CTO-Crossing Catheter
K201330 · Avinger, Inc. · Sep 2020
SoundBite Console, SoundBite Active Wire 18
K192211 · Soundbite Medical Solution, Inc. · Jan 2020
XableCath Crossing Catheter
K183357 · Xablecath, Inc. · Jan 2019
Pioneer Plus Catheter
K162418 · Philips Volcano · Dec 2016
CROSSER CTO Recanalization Catheter
K161208 · Bard Peripheral Vacular, Inc. · May 2016
ELITECROSS Support Catheter
K150187 · Cordis Corporation, A Johnson & Johnson Company · May 2015