Cleared Traditional

K881966 - ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER

K881966 is an FDA 510(k) clearance for ELECTROPHYSIOLOGY ELECTRODE CATH. W/SIL..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K881966 · C.R. Bard, Inc. · Cardiovascular device
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Oct 1988
Decision
146d
Days
Class 2
Risk

K881966 is an FDA 510(k) clearance for the ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER. 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 4, 1988 after a review of 146 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

FDA 510(k) Submission Details - K881966

510(k) Number K881966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1988
Decision Date October 04, 1988
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRF Device Classification - Class 2, Special Controls

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 140
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K881966.
MODIFIED EPICARDIAL ARRAY
K902228 · C.R. Bard, Inc. · Jul 1990
DAIG ELECTROPHYSIOLOGY CATHETER
K894500 · Daig Corp. · Sep 1989
BARD(R) TIP DEFLECTING ELECTRODE CATHETER
K891908 · C.R. Bard, Inc. · Jun 1989
BARD DESAI CATHETER ELECTRODE
K873995 · C.R. Bard, Inc. · Jan 1988
BARD OCTAPOLAR ELECTRODE CATHETER
K874208 · C.R. Bard, Inc. · Dec 1987
BARD EPICARDIAL ELECTRODE ARRAY
K872231 · C.R. Bard, Inc. · Oct 1987