Cleared Traditional

ENDOCARD. PACING LEAD STD. LENGTH PL202 (K800350) - FDA 510(k) Clearance

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

K800350 · Daig Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1980
Decision
103d
Days
Class 3
Risk

K800350 is an FDA 510(k) clearance for the ENDOCARD. PACING LEAD STD. LENGTH PL202. 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 May 28, 1980 after a review of 103 days - within the typical 510(k) review window.

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 K800350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1980
Decision Date May 28, 1980
Days to Decision 103 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 125d · This submission: 103d
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 K800350.
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
LIFELINE - ENDOCARDIAL PACING LEAD
K792168 · Intermedics, Inc. · Nov 1979
CORDIS PERMANENT PERVENOUS CARDIAC LEADS
K791768 · Cordis Corp. · Nov 1979