Cleared Traditional

TrapLiner catheter

K161901 · Vascular Solutions, Inc. · Cardiovascular
Feb 2017
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K161901 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 February 3, 2017, 207 days after receiving the submission on July 11, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K161901 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2016
Decision Date February 03, 2017
Days to Decision 207 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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