Cleared Traditional

K963074 - HARMAC QUADPOLAR MAPPING PACING CATHETER

K963074 is an FDA 510(k) clearance for HARMAC QUADPOLAR MAPPING PACING CATHETER, manufactured by Harmac Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 362-day FDA review.

K963074 · Harmac Medical Products, Inc. · Cardiovascular device
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Jun 1997
Decision
362d
Days
Class 2
Risk

K963074 is an FDA 510(k) clearance for the HARMAC QUADPOLAR MAPPING PACING CATHETER. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Harmac Medical Products, Inc. (Buffalo, US). The FDA issued a Cleared decision on June 25, 1997 after a review of 362 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Harmac Medical Products, Inc. devices

FDA 510(k) Submission Details - K963074

510(k) Number K963074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1996
Decision Date June 25, 1997
Days to Decision 362 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 125d · This submission: 362d
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 136
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K963074.
PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)
K970853 · Cardima, Inc. · Nov 1997
VIKING DIAGNOSTIC ELECTRODE CATHETER
K971265 · C.R. Bard, Inc. · Oct 1997
ARRHYTHMIA MAPPING SYSTEM (8100/8300)
K965066 · Cardiac Pathways Corp. · Aug 1997
IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
K961924 · Irvine Biomedical, Inc. · Apr 1997
PATHFINDER
K955802 · Cardima, Inc. · Jan 1997
GYRO TIP EP CATHETER
K955847 · Cardiac Assist Devices, Inc. · Jan 1997