Cleared Traditional

K955712 - USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING

K955712 is an FDA 510(k) clearance for USCI BIPOLAR BALLOON PACING ELECTRODE W..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K955712

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.

LDF Device Classification - Class 2, Special Controls

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 92
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