Cleared Traditional

K120298 - CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE

K120298 is an FDA 510(k) clearance for CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE, manufactured by St. Jude Medical, Cardiac Rhythm Management Divisi. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K120298 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
98d
Days
Class 2
Risk

K120298 is an FDA 510(k) clearance for the CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, US). The FDA issued a Cleared decision on May 8, 2012 after a review of 98 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.

FDA 510(k) Submission Details - K120298

510(k) Number K120298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2012
Decision Date May 08, 2012
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 742
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K120298.
MANTARAY GUIDEWIRES
K121745 · Bridgepoint Medical · Jul 2012
NAVIS TORQUER
K112674 · Navis Medical,Inc · Jul 2012
SUNMED GUIDE WIRE
K120119 · Sunny Medical Device (Shenzhen) Co., Ltd. · May 2012
WHOLEY GUIDE WIRE SYSTEM
K120863 · Covidien, LLC · Apr 2012
MANTARAY GUIDEWIRES
K120881 · Bridgepoint Medical · Apr 2012
14 WIRE STANDARD, 14 WIRE LS
K113454 · Micro Therapeutics, Inc. · Feb 2012
K120298 · CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
Download PDF FDA Summary St. Jude Medical, Car…