Cleared Traditional

K170349 - RA-308 Excimer Laser System

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
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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
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PDU Catheter For Crossing Total Occlusions

All 40
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
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
K140185 · Avinger, Inc. · May 2014
TRUEPATH CTO DEVICE
K140288 · Boston Scientific Corp · Apr 2014
OFFROAD RE-ENTRY CATHETER SYSTEM
K131914 · Boston Scientific Corp · Oct 2013