Cleared Traditional

K052347 - TITAN STEERABLE (PTCA) GUIDEWIRE

K052347 is an FDA 510(k) clearance for TITAN STEERABLE (PTCA) GUIDEWIRE, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K052347 · Lake Region Mfg., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
172d
Days
Class 2
Risk

K052347 is an FDA 510(k) clearance for the TITAN STEERABLE (PTCA) GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on February 17, 2006 after a review of 172 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 Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K052347

510(k) Number K052347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2005
Decision Date February 17, 2006
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K052347.
HI-TORQUE WHISPER VIEW GUIDE WIRE
K061453 · Guidant Corp. · Jun 2006
MICRUS GUIDE WIRE, WATUSI 0.014
K053265 · Micrus Endovascular Corporation · Apr 2006
TITAN GUIDEWIRE
K060454 · Lake Region Mfg., Inc. · Mar 2006
ASAHI PTCA GUIDE WIRE
K052339 · Asahi Intecc Co., Ltd. · Nov 2005
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
K052783 · Boston Scientific Corp · Oct 2005
ASAHI PTCA GUIDE WIRE FIELDER
K052022 · Asahi Intecc Co., Ltd. · Aug 2005