Cleared Traditional

K183357 - XableCath Crossing Catheter

K183357 is the FDA 510(k) clearance for XableCath Crossing Catheter by Xablecath, Inc.. It is a Class 2 Cardiovascular device (product code PDU) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K183357 · Xablecath, Inc. · Cardiovascular device
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Jan 2019
Decision
48d
Days
Class 2
Risk

K183357 is an FDA 510(k) clearance for the XableCath Crossing Catheter. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Xablecath, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 21, 2019 after a review of 48 days - a notably fast clearance cycle.

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: 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 Xablecath, Inc. devices

Submission Details

510(k) Number K183357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2018
Decision Date January 21, 2019
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
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 K183357.
SoundBite Crossing System - Peripheral (14P)
K210839 · Soundbite Medical Solutions, Inc. · Apr 2021
Tigereye CTO-Crossing Catheter
K201330 · Avinger, Inc. · Sep 2020
SoundBite Console, SoundBite Active Wire 18
K192211 · Soundbite Medical Solution, Inc. · Jan 2020
TRUEPATH CTO DEVICE
K140288 · Boston Scientific Corp · Apr 2014
OFFROAD RE-ENTRY CATHETER SYSTEM
K131914 · Boston Scientific Corp · Oct 2013
CROSSER RECANALIZATION SYSTEM
K112308 · C.R. Bard, Inc. · Aug 2011