Cleared Traditional

K053251 - TECHDEVICE GUIDEWIRE

K053251 is an FDA 510(k) clearance for TECHDEVICE GUIDEWIRE, manufactured by Techdevice Corporation. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K053251 · Techdevice Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
107d
Days
Class 2
Risk

K053251 is an FDA 510(k) clearance for the TECHDEVICE GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Techdevice Corporation (Watertown, US). The FDA issued a Cleared decision on March 8, 2006 after a review of 107 days - within the typical 510(k) review window.

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 Techdevice Corporation devices

FDA 510(k) Submission Details - K053251

510(k) Number K053251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2005
Decision Date March 08, 2006
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 521
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K053251.
TREASURE
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TITAN STEERABLE (PTCA) GUIDEWIRE
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ASAHI PTCA GUIDE WIRE
K052339 · Asahi Intecc Co., Ltd. · Nov 2005
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K052783 · Boston Scientific Corp · Oct 2005