Cleared Traditional

K141054 - DISTAL ACCESS TORQUE DEVICE

K141054 is an FDA 510(k) clearance for DISTAL ACCESS TORQUE DEVICE, manufactured by Distal Access, LLC. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K141054 · Distal Access, LLC · Cardiovascular device
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Dec 2014
Decision
236d
Days
Class 2
Risk

K141054 is an FDA 510(k) clearance for the DISTAL ACCESS TORQUE DEVICE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Distal Access, LLC (Park City, US). The FDA issued a Cleared decision on December 10, 2014 after a review of 236 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Distal Access, LLC devices

FDA 510(k) Submission Details - K141054

510(k) Number K141054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2014
Decision Date December 10, 2014
Days to Decision 236 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 125d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 600
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