Cleared Traditional

Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter

K212211 · Vascular Solutions, LLC · Cardiovascular
Feb 2022
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K212211 is an FDA 510(k) clearance for the Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Vascular Solutions, LLC (Maple Grove, US). The FDA issued a Cleared decision on February 9, 2022, 209 days after receiving the submission on July 15, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K212211 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2021
Decision Date February 09, 2022
Days to Decision 209 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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