Cleared Traditional

POROUS TIP ENDOCARDIAL LEAD (K830743) - FDA 510(k) Clearance

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

K830743 · Daig Corp. · Cardiovascular device
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May 1983
Decision
62d
Days
Class 3
Risk

K830743 is an FDA 510(k) clearance for the POROUS TIP ENDOCARDIAL LEAD. 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 9, 1983 after a review of 62 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 K830743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1983
Decision Date May 09, 1983
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
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 K830743.
LIFELINE TLE 484-02
K843394 · Intermedics, Inc. · Sep 1984
LIFELINE PACING LEADS #471-07 &09
K832409 · Intermedics, Inc. · Aug 1983
MEDTRONIC MODELS 4012 & 4512
K832099 · Medtronic Vascular · Jul 1983
LIFELINE ENDOCARDIAL PACING LEAD #479-05
K830782 · Intermedics, Inc. · Apr 1983
LIFELINE UNIPOLAR J-LEAD #483-05
K830463 · Intermedics, Inc. · Feb 1983
LIFELINE -UNIPOLAR LEAD #487-05
K823508 · Intermedics, Inc. · Jan 1983