Cleared Traditional

K042373 - GALEO FOCUS GUIDE WIRE

K042373 is the FDA 510(k) clearance for GALEO FOCUS GUIDE WIRE by Biotronik, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K042373 · Biotronik, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2005
Decision
182d
Days
Class 2
Risk

K042373 is an FDA 510(k) clearance for the GALEO FOCUS GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on March 2, 2005 after a review of 182 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 Biotronik, Inc. devices

Submission Details

510(k) Number K042373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2004
Decision Date March 02, 2005
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 498
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K042373.
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
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CANALIZER HYDROPHILIC GUIDE WIRE
K050873 · Medical Device Technologies, Inc. · May 2005
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES
K043422 · Asahi Intecc Co., Ltd. · Jan 2005
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592 · Cordis Corp. · Dec 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · Cook, Inc. · Nov 2004