Cleared Traditional

K873438 - USCI 8F LARGE LUMEN SOFT TIP GUIDE CATH...

K873438 is the FDA 510(k) clearance for USCI 8F LARGE LUMEN SOFT TIP GUIDE CATH... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K873438 · C.R. Bard, Inc. · Cardiovascular device
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Nov 1987
Decision
92d
Days
Class 2
Risk

K873438 is an FDA 510(k) clearance for the USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on November 27, 1987 after a review of 92 days - within the typical 510(k) review window.

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 K873438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1987
Decision Date November 27, 1987
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
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 K873438.
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051 · C.R. Bard, Inc. · Oct 1988
SLIP-COAT(TM) CATHETERS
K882796 · Cook, Inc. · Jul 1988
TARGET THERAPEUTICS STERILE PRODUCTS
K874815 · Target Therapeutics · Feb 1988
GUIDING CATHETER
K873004 · Mallinckrodt Critical Care · Sep 1987
DOUBLE LUMEN CATHETER
K872248 · Cordis Corp. · Aug 1987
NUMED BALLOON WEDGE PRESSURE CATHETER
K864943 · NuMED, Inc. · Feb 1987