Cleared Traditional

PERMANENT & TEMP. PACEMAKER ELECTRODE (K800795) - FDA 510(k) Clearance

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

K800795 · Daig Corp. · Cardiovascular device
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Jun 1980
Decision
82d
Days
Class 3
Risk

K800795 is an FDA 510(k) clearance for the PERMANENT & TEMP. PACEMAKER 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 June 30, 1980 after a review of 82 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 K800795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1980
Decision Date June 30, 1980
Days to Decision 82 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 125d · This submission: 82d
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 K800795.
MEDTRONIC MODEL 6958
K800870 · Medtronic Vascular · Nov 1980
POLYFLEX IMPLANTABLE PACING LEAD
K802293 · Intermedics, Inc. · Oct 1980
MEDTRONIC MODEL 69575
K800944 · Medtronic Vascular · Sep 1980
LIFELINE TLE (TRAEBECULAR LODGING ELEC
K792300 · Intermedics, Inc. · Jun 1980
LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL
K792301 · Intermedics, Inc. · Jun 1980
LIFELINE TLE ENDOCARDIAL PACING LEAD,
K792604 · Intermedics, Inc. · Dec 1979