Cleared Traditional

Langston dual lumen catheter

K170544 · Vascular Solutions, Inc. · Cardiovascular
Nov 2017
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K170544 is an FDA 510(k) clearance for the Langston dual lumen catheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on November 17, 2017, 266 days after receiving the submission on February 24, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K170544 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2017
Decision Date November 17, 2017
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200

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