Cleared Traditional

K782004 - LEAD

K782004 is the FDA 510(k) clearance for LEAD by Daig Corp.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K782004 · Daig Corp. · Cardiovascular device
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Dec 1978
Decision
11d
Days
Class 3
Risk

K782004 is an FDA 510(k) clearance for the LEAD, TIMED PACING, IMPLANTABLE. 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 December 15, 1978 after a review of 11 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 K782004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1978
Decision Date December 15, 1978
Days to Decision 11 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
114d faster than avg
Panel avg: 125d · This submission: 11d
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 386
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K782004.
ENDOCARIDAL PACING LEAD UNIPOLAR 477
K781525 · Intermedics, Inc. · Feb 1979
SUTURELESS MUOCARDINE PACING LEADS 471
K781570 · Intermedics, Inc. · Feb 1979
LEAD, SUTURELESS MYOCARDIAL
K782087 · Daig Corp. · Jan 1979
ELECTRODES, IMPLANTABLE WITH ADAPTER
K781849 · Telectronics, Inc. · Dec 1978
PACING LEADS MODEL UL-811 AND UL-813
K781776 · Pacesetter Systems · Oct 1978
PACEMAKER, ELECTRODE, PERMANENT & TEMP.
K780246 · Daig Corp. · Aug 1978