Cleared Traditional

K891908 - BARD TIP DEFLECTING ELECTRODE CATHETER

K891908 is the FDA 510(k) clearance for BARD TIP DEFLECTING ELECTRODE CATHETER by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K891908 · C.R. Bard, Inc. · Cardiovascular device
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Jun 1989
Decision
70d
Days
Class 2
Risk

K891908 is an FDA 510(k) clearance for the BARD(R) TIP DEFLECTING ELECTRODE CATHETER. 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 June 5, 1989 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K891908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1989
Decision Date June 05, 1989
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
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 K891908.
BARD(R) ENDOCARDIAL BALLOON ARRAY
K911140 · C.R. Bard, Inc. · May 1991
MODIFIED EPICARDIAL ARRAY
K902228 · C.R. Bard, Inc. · Jul 1990
DAIG ELECTROPHYSIOLOGY CATHETER
K894500 · Daig Corp. · Sep 1989
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