Cleared Traditional

K802058 - MAPPING PROBE MODEL #6540

K802058 is the FDA 510(k) clearance for MAPPING PROBE MODEL #6540 by Cardiac Pacemakers, Inc.. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K802058 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Nov 1980
Decision
86d
Days
Class 2
Risk

K802058 is an FDA 510(k) clearance for the MAPPING PROBE MODEL #6540. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 19, 1980 after a review of 86 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K802058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1980
Decision Date November 19, 1980
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 92
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K802058.
BARD OCTAPOLAR ELECTRODE CATHETER
K874208 · C.R. Bard, Inc. · Dec 1987
BARD EPICARDIAL ELECTRODE ARRAY
K872231 · C.R. Bard, Inc. · Oct 1987
MODEL TP THERMISTOR PROBE
K831528 · Scimed Life Systems, Inc. · Jun 1983
PROBE, TEMPERATURE, SYSTEM, SARNS
K770709 · 3M Health Care, Sarns · Apr 1977
CITADEL REFERENCE ELECTRODE
K770477 · Sherwood Medical Industries · Mar 1977