Cleared Traditional

K830782 - LIFELINE ENDOCARDIAL PACING LEAD #479-05

K830782 is an FDA 510(k) clearance for LIFELINE ENDOCARDIAL PACING LEAD #479-05, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K830782 · Intermedics, Inc. · Cardiovascular device
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Apr 1983
Decision
38d
Days
Class 3
Risk

K830782 is an FDA 510(k) clearance for the LIFELINE ENDOCARDIAL PACING LEAD #479-05. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1983 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K830782

510(k) Number K830782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1983
Decision Date April 18, 1983
Days to Decision 38 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
87d faster than avg
Panel avg: 125d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K830782.
MODEL SF. D&SX.D PACEMAKER LEADS
K823897 · Oscor, Inc. · Apr 1983
MODEL MF..D & MX..D PACEMAKER LEADS
K823898 · Oscor, Inc. · Apr 1983
IMPLANTABLE PACING LEAD CCS MODEL SV-101
K830828 · Cardiac Control Systems, Inc. · Apr 1983
VASCULAR PRODUCTS IMPLANTABLE PACING
K830950 · Oscor, Inc. · Apr 1983
MODEL ZY PACEMAKER LEAD-VARIOUS
K823890 · Oscor, Inc. · Mar 1983
MODEL KY PACEMAKER LEAD - VARIOUS
K823891 · Oscor, Inc. · Mar 1983