Cleared Traditional

K872231 - BARD EPICARDIAL ELECTRODE ARRAY

K872231 is the FDA 510(k) clearance for BARD EPICARDIAL ELECTRODE ARRAY by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K872231 · C.R. Bard, Inc. · Cardiovascular device
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Oct 1987
Decision
122d
Days
Class 2
Risk

K872231 is an FDA 510(k) clearance for the BARD EPICARDIAL ELECTRODE ARRAY. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 K872231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1987
Decision Date October 09, 1987
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 96
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K872231.
ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER
K881966 · C.R. Bard, Inc. · Oct 1988
BARD DESAI CATHETER ELECTRODE
K873995 · C.R. Bard, Inc. · Jan 1988
BARD OCTAPOLAR ELECTRODE CATHETER
K874208 · C.R. Bard, Inc. · Dec 1987
ELECATH GALLAGHER MAPPING CATHETER
K844805 · Electro-Catheter Corp. · Jan 1985
MODEL TP THERMISTOR PROBE
K831528 · Scimed Life Systems, Inc. · Jun 1983
MAPPING PROBE MODEL #6540
K802058 · Cardiac Pacemakers, Inc. · Nov 1980