Cleared Traditional

Tractus Crossing Support Catheter

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

About This 510(k) Submission

K180889 is an FDA 510(k) clearance for the Tractus Crossing Support Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Tractus Vascular, LLC (Eatontown, US). The FDA issued a Cleared decision on December 7, 2018, 247 days after receiving the submission on April 4, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K180889 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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