Cleared Traditional

TURNPIKE CATHETER

K142065 · Vascular Solutions, Inc. · Cardiovascular
Nov 2014
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K142065 is an FDA 510(k) clearance for the TURNPIKE 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 November 25, 2014, 118 days after receiving the submission on July 30, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K142065 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2014
Decision Date November 25, 2014
Days to Decision 118 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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