Cleared Traditional

K972803 - TRACER O-T-W MAPPING DEVICE

K972803 is an FDA 510(k) clearance for TRACER O-T-W MAPPING DEVICE, manufactured by Cardima, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 652-day FDA review.

K972803 · Cardima, Inc. · Cardiovascular device
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May 1999
Decision
652d
Days
Class 2
Risk

K972803 is an FDA 510(k) clearance for the TRACER O-T-W MAPPING DEVICE. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Cardima, Inc. (Fremont, US). The FDA issued a Cleared decision on May 11, 1999 after a review of 652 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Cardima, Inc. devices

FDA 510(k) Submission Details - K972803

510(k) Number K972803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1997
Decision Date May 11, 1999
Days to Decision 652 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
527d slower than avg
Panel avg: 125d · This submission: 652d
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 111
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K972803.
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
K002333 · Biosense Webster, Inc. · Aug 2000
CORDIS 13F CATHETER SHEATH INTRODUCER
K000753 · Cordis Corp. · Apr 2000
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
K992373 · C.R. Bard, Inc. · Nov 1999
ELECTRODE SWITCHBOX, MODEL 11-081002
K982835 · Cardima, Inc. · Oct 1998
CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210
K982415 · Cordis Webster, Inc. · Aug 1998
STABLEMAPR STEERABLE INTRACARDIAC CATHETERS
K981642 · Medtronic Cardiorhythm · Aug 1998