Cleared Traditional

PACEMAKER, PERM. & TEMP., ELECTRODE (K772197) - FDA 510(k) Clearance

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

K772197 · Daig Corp. · Cardiovascular device
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Jan 1978
Decision
66d
Days
Class 3
Risk

K772197 is an FDA 510(k) clearance for the PACEMAKER, PERM. & TEMP., ELECTRODE. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Daig Corp. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1978 after a review of 66 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 Daig Corp. devices

Submission Details

510(k) Number K772197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1977
Decision Date January 30, 1978
Days to Decision 66 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 125d · This submission: 66d
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 K772197.
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
BIPOLAR LEADS, DISP.
K772103 · Medtronic Vascular · Nov 1977