Cleared Traditional

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) (K210664) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210664 · Ra Medical Systems,Inc · Cardiovascular device
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Jul 2021
Decision
144d
Days
Class 2
Risk

K210664 is an FDA 510(k) clearance for the DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101). 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 July 27, 2021 after a review of 144 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

Submission Details

510(k) Number K210664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2021
Decision Date July 27, 2021
Days to Decision 144 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
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K210664.
GoBack Crossing Catheter
K211802 · Upstream Peripheral Technologies, Ltd. · Mar 2022
Tigereye CTO-Crossing Catheter
K212468 · Avinger, Inc. · Jan 2022
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K203363 · C.R. Bard, Inc. · Aug 2021
SoundBite Crossing System - Peripheral (14P)
K210839 · Soundbite Medical Solutions, Inc. · Apr 2021
Tigereye CTO-Crossing Catheter
K201330 · Avinger, Inc. · Sep 2020
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K192211 · Soundbite Medical Solution, Inc. · Jan 2020