Cleared Traditional

K142065 - TURNPIKE CATHETER

K142065 is the FDA 510(k) clearance for TURNPIKE CATHETER by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

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

K142065 is an FDA 510(k) clearance for the TURNPIKE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 25, 2014 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vascular Solutions, Inc. devices

Submission Details

510(k) Number K142065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 459
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K142065.
Benchmark Intracranial Access System
K142321 · Penumbra, Inc. · Jan 2015
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
K142235 · St Jude Medical · Dec 2014
CPS Direct MediGuide Enabled outer catheter
K142239 · St Jude Medical · Dec 2014
SOFIA DISTAL ACCESS CATHETER
K142014 · MicroVention, Inc. · Oct 2014
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
K140080 · Codman & Shurtleff, Inc. · Apr 2014
ENVOY GUIDING CATHETER
K140307 · Codman & Shurtleff, Inc. · Apr 2014