Cleared Traditional

PERMANENT & TEMPORARY PACEMAKER ELECTR. (K820262) - FDA 510(k) Clearance

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

K820262 · Diag Corp. · Cardiovascular device
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Mar 1982
Decision
38d
Days
Class 3
Risk

K820262 is an FDA 510(k) clearance for the PERMANENT & TEMPORARY PACEMAKER ELECTR.. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Diag Corp. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1982 after a review of 38 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 Diag Corp. devices

Submission Details

510(k) Number K820262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1982
Decision Date March 12, 1982
Days to Decision 38 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
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 K820262.
MEDTRONIC #6993
K820989 · Medtronic Vascular · Aug 1982
POROUS SURFACED PLATINUM IRIDIUM
K821889 · Cordis Corp. · Aug 1982
IMPLANTIBLE SUTURE SLEEVE
K820487 · Intermedics, Inc. · Apr 1982
POLY-FLEX PACING LEADS
K813028 · Intermedics, Inc. · Dec 1981
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD
K812989 · Intermedics, Inc. · Nov 1981
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD
K812990 · Intermedics, Inc. · Nov 1981