Cleared Traditional

K790074 - MEDTRONIC MODEL 6971

K790074 is the FDA 510(k) clearance for MEDTRONIC MODEL 6971 by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K790074 · Medtronic Vascular · Cardiovascular device
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Mar 1979
Decision
77d
Days
Class 3
Risk

K790074 is an FDA 510(k) clearance for the MEDTRONIC MODEL 6971. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on March 29, 1979 after a review of 77 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 Medtronic Vascular devices

Submission Details

510(k) Number K790074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1979
Decision Date March 29, 1979
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 364
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K790074.
BIPOLAR PERNENOUS VENTRICULAR LEAD
K790344 · Cordis Corp. · Apr 1979
MEDTRONIC MODEL 6972
K790462 · Medtronic Vascular · Apr 1979
LEAD MODELS MUM 1260, MUM 1290
K790386 · Ela Medical, Inc. · Apr 1979
MEDTRONIC TEMPTRON
K790261 · Medtronic Vascular · Feb 1979
LIFELINE PACING LEAD MODEL 465-01
K781497 · Intermedics, Inc. · Feb 1979
LIFELINE BIPOLAR PACING LEAD MOD. 466-01
K781498 · Intermedics, Inc. · Feb 1979