Cleared Traditional

L-12, L-21, AND L-22 ELECTRODES (K780569) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K780569 · Coratomic, Inc. · Cardiovascular device
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Jun 1978
Decision
64d
Days
Class 3
Risk

K780569 is an FDA 510(k) clearance for the L-12, L-21, AND L-22 ELECTRODES. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Coratomic, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1978 after a review of 64 days - a notably fast clearance 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: High-complexity regulatory submission. High regulatory complexity 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 Coratomic, Inc. devices

Submission Details

510(k) Number K780569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1978
Decision Date June 14, 1978
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K780569.
BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902
K780622 · Medtronic Vascular · Jul 1978
ENDOCARDIAL ATRIAL PACING LEAD, M. 6994
K780623 · Medtronic Vascular · Jul 1978
LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED
K780621 · Medtronic Vascular · Jul 1978
SUTURELESS MYOCARDIAL PACING LEAD
K780446 · Medtronic Vascular · May 1978
VENTRICULAR LEADS
K772203 · Medtronic Vascular · Jan 1978
PACING LEAD MODEL 6991A
K772104 · Medtronic Vascular · Nov 1977