Cleared Traditional

K183305 - Crossing Support Catheter

K183305 is an FDA 510(k) clearance for Crossing Support Catheter, manufactured by Tractus Vascular, LLC. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K183305 · Tractus Vascular, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
250d
Days
Class 2
Risk

K183305 is an FDA 510(k) clearance for the Crossing Support Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Tractus Vascular, LLC (Eatontown, US). The FDA issued a Cleared decision on August 5, 2019 after a review of 250 days - an extended review 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: 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 Tractus Vascular, LLC devices

FDA 510(k) Submission Details - K183305

510(k) Number K183305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2018
Decision Date August 05, 2019
Days to Decision 250 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
125d slower than avg
Panel avg: 125d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K183305.
Medtronic 6F Taiga Guiding Catheter
K192296 · Medtronic Vascular · Sep 2019
SelectFlex 072 Neurovascular Access System
K191664 · Q'Apel Medical · Aug 2019
Turnpike Catheter
K191560 · Vascular Solutions, LLC · Aug 2019
CerusEndo Microcatheter
K182487 · Cerus Endovascular, Inc. · Jul 2019
087 Balloon Guide Catheter System
K190749 · Q'Apel · Jul 2019
Scepter Mini Occlusion Balloon Catheter
K182829 · MicroVention, Inc. · Jul 2019