Cleared Traditional

K180889 - Tractus Crossing Support Catheter

K180889 is an FDA 510(k) clearance for Tractus 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 247-day FDA review.

K180889 · Tractus Vascular, LLC · Cardiovascular device
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Dec 2018
Decision
247d
Days
Class 2
Risk

K180889 is an FDA 510(k) clearance for the Tractus 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 December 7, 2018 after a review of 247 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 - K180889

510(k) Number K180889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2018
Decision Date December 07, 2018
Days to Decision 247 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
122d slower than avg
Panel avg: 125d · This submission: 247d
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 K180889.
Xcess Guiding Catheter
K180797 · Curatia Medical Co. · Dec 2018
Selectra Catheters, Selectra Accessory Kit
K183265 · Biotronik, Inc. · Dec 2018
Route 92 Medical Delivery Catheter
K182512 · Route 92 Medical, Inc. · Dec 2018
React 71 Catheter
K182097 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Nov 2018
Teleport Microcatheter
K182360 · Orbusneich Medical Trading, Inc. · Nov 2018
GORE Tri-Lumen Catheter
K180919 · W. L. Gore and Associates, Inc. · Oct 2018