Cleared Traditional

K960479 - ARROW BIPOLAR PACING/BALLOON WEDGE PRES...

K960479 is an FDA 510(k) clearance for ARROW BIPOLAR PACING/BALLOON WEDGE PRES..., manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K960479 · Arrow Intl., Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
258d
Days
Class 2
Risk

K960479 is an FDA 510(k) clearance for the ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on October 17, 1996 after a review of 258 days - an extended review cycle.

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. 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K960479

510(k) Number K960479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1996
Decision Date October 17, 1996
Days to Decision 258 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
133d slower than avg
Panel avg: 125d · This submission: 258d
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 81
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K960479.
INTRODUCER SHEATH AND DILATOR
K971165 · Boston Scientific Corp · Jul 1997
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD
K963898 · Medtronic Vascular · Jul 1997
UNIPOLAR IPG GROUND CABLE, MODEL 5473
K961520 · Medtronic Vascular · Nov 1996
USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING
K955712 · C.R. Bard, Inc. · Oct 1996
RV PACING LEAD
K962467 · Abbott Laboratories · Sep 1996
FLEXON TEMPORARY CARDIAC PACER LEAD
K955722 · Davis & Geck, Inc. · Mar 1996