Cleared Traditional

ENDOCARDIAL PACING LEAD, MODEL 476-01 (K790548) - FDA 510(k) Clearance

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

K790548 · Intermedics, Inc. · Cardiovascular device
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Jun 1979
Decision
73d
Days
Class 3
Risk

K790548 is an FDA 510(k) clearance for the ENDOCARDIAL PACING LEAD, MODEL 476-01. 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 June 1, 1979 after a review of 73 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

Submission Details

510(k) Number K790548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1979
Decision Date June 01, 1979
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 221
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K790548.
MEDTRONIC MODELS 69914/699OU
K791667 · Medtronic Vascular · Sep 1979
MEDTRONIC MODEL 6957
K790429 · Medtronic Vascular · Jul 1979
MODEL 6971 W/ DBS WIRE
K790988 · Medtronic Vascular · Jun 1979
MEDTRONIC MODELS 6907/6901
K790766 · Medtronic Vascular · May 1979
BIPOLAR PERNENOUS VENTRICULAR LEAD
K790344 · Cordis Corp. · Apr 1979
MEDTRONIC MODEL 6972
K790462 · Medtronic Vascular · Apr 1979