Cleared Special

TrapLiner catheter

K180088 · Vascular Solutions, Inc. · Cardiovascular
Apr 2018
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K180088 is an FDA 510(k) clearance for the TrapLiner catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on April 4, 2018, 82 days after receiving the submission on January 12, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K180088 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 2018
Decision Date April 04, 2018
Days to Decision 82 days
Submission Type Special
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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