Cleared Traditional

K925074 - USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING

K925074 is an FDA 510(k) clearance for USCI LUMISILK GUIDE WIRE WITH PRO/PEL C..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K925074 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
145d
Days
Class 2
Risk

K925074 is an FDA 510(k) clearance for the USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on March 1, 1993 after a review of 145 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K925074

510(k) Number K925074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1992
Decision Date March 01, 1993
Days to Decision 145 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
20d slower than avg
Panel avg: 125d · This submission: 145d
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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K925074.
AMPLATZ GUIDEWIRES
K930622 · Meadox Medicals, Div. Boston Scientific Corp. · Apr 1993
SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR
K926457 · Scimed Life Systems, Inc. · Apr 1993
CORDIS REFLEX STEERABLE GUIDEWIRE
K930091 · Cordis Corp. · Apr 1993
.25' ULTRA-SELECT GUIDEWIRE
K922060 · Microvena Corp. · Feb 1993
ACS HI-TORQUE BALANCE(TM) GUIDE WIRE
K925381 · Advanced Cardiovascular Systems, Inc. · Feb 1993
SCHNEIDER HYDRO-SIL GUIDEWIRE
K925804 · Schneider Intl., Ltd. · Feb 1993