Cleared Traditional

K121398 - CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)

K121398 is an FDA 510(k) clearance for CHARLIE GUIDEWIRE (REGULAR), manufactured by Guidepath Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K121398 · Guidepath Medical, Inc. · Cardiovascular device
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Dec 2012
Decision
218d
Days
Class 2
Risk

K121398 is an FDA 510(k) clearance for the CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF). Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Guidepath Medical, Inc. (Austin, US). The FDA issued a Cleared decision on December 13, 2012 after a review of 218 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 Guidepath Medical, Inc. devices

FDA 510(k) Submission Details - K121398

510(k) Number K121398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2012
Decision Date December 13, 2012
Days to Decision 218 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
93d slower than avg
Panel avg: 125d · This submission: 218d
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 607
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K121398.
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
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K123067 · Abbott Vascular, Inc. · Jan 2013
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K123609 · Merit Medical Systems, Inc. · Jan 2013
HI-TORQUE COMMAND GUIDE WIRE FAMILY
K122573 · Abbott Vascular, Inc. · Nov 2012
TORQUE DEVICE
K123024 · Boston Scientific Corporation · Oct 2012
OSTIAL PRO STENT POSITIONING SYSTEM
K122089 · Merit Medical Systems, Inc. · Sep 2012