Cleared Traditional

K955712 - USCI BIPOLAR BALLOON PACING ELECTRODE W...

K955712 is the FDA 510(k) clearance for USCI BIPOLAR BALLOON PACING ELECTRODE W... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K955712 · C.R. Bard, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
301d
Days
Class 2
Risk

K955712 is an FDA 510(k) clearance for the USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on October 11, 1996 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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. Elevated predicate reliance profile. 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 K955712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1995
Decision Date October 11, 1996
Days to Decision 301 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 125d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 72
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K955712.
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD
K963898 · Medtronic Vascular · Jul 1997
UNIPOLAR IPG GROUND CABLE, MODEL 5473
K961520 · Medtronic Vascular · Nov 1996
ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
K960479 · Arrow Intl., Inc. · Oct 1996
RV PACING LEAD
K962467 · Abbott Laboratories · Sep 1996
FLEXON TEMPORARY CARDIAC PACER LEAD
K955722 · Davis & Geck, Inc. · Mar 1996
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494
K954809 · Medtronic Vascular · Dec 1995