Cleared Traditional

K831854 - USCI ANGIOGRAPHIC BALLOON CATHETER

K831854 is the FDA 510(k) clearance for USCI ANGIOGRAPHIC BALLOON CATHETER by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K831854 · C.R. Bard, Inc. · Cardiovascular device
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Oct 1983
Decision
133d
Days
Class 2
Risk

K831854 is an FDA 510(k) clearance for the USCI ANGIOGRAPHIC BALLOON CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on October 20, 1983 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 K831854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1983
Decision Date October 20, 1983
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 52
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K831854.
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836 · Instrumentation Laboratory CO · Feb 1984
HEPARIN-COATED BALLOON THERMODILUT
K833572 · Critikon Company, LLC · Jan 1984
INFUSION PORT BALLOON THERMODILUTION
K833918 · Critikon Company, LLC · Jan 1984
FLOW-DIRECTED HEPARIN COATED THERMODIL
K832957 · Sorensen Research · Sep 1983
ELECATH BALTHERM TLC THERMAL DILUTION
K831945 · Electro-Catheter Corp. · Aug 1983
CARDIAC OUTPUT MEASURE SYSTEM
K831185 · Cook, Inc. · May 1983