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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQX Wire, Guide, Catheter

All 741
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K141054.
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE
K140536 · Lake Region Medical · Dec 2014
PRELUDE PLASTIC JACKETED GUIDE WIRE
K142051 · Merit Medical Systems, Inc. · Dec 2014
MERIT HYDROPHILIC GUIDEWIRE
K141295 · Merit Medical Systems, Inc. · Dec 2014
PREDICATE III GUIDEWIRE
K142393 · Lake Region Medical · Nov 2014
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector
K142254 · St Jude Medical · Nov 2014
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
K141339 · Asahi Intecc Co., Ltd. · Oct 2014