Cleared Traditional

K920980 - USCI LINX EZ GUIDE WIRE EXTENSION W/PRO...

K920980 is the FDA 510(k) clearance for USCI LINX EZ GUIDE WIRE EXTENSION W/PRO... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K920980 · C.R. Bard, Inc. · Cardiovascular device
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Aug 1992
Decision
175d
Days
Class 2
Risk

K920980 is an FDA 510(k) clearance for the USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on August 24, 1992 after a review of 175 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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

Submission Details

510(k) Number K920980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date August 24, 1992
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 290
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K920980.
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CARDIAC CATHERIZATION KIT
K914299 · Abbott Laboratories · Jun 1992
CORDIS ANGIOGRAPHIC DOPPLER CATHER
K915498 · Cordis Corp. · Apr 1992
DESERET GUIDEWIRE INTRODUCER II
K920407 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992