Cleared Traditional

K790988 - MODEL 6971 W/ DBS WIRE

K790988 is the FDA 510(k) clearance for MODEL 6971 W/ DBS WIRE by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K790988 · Medtronic Vascular · Cardiovascular device
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Jun 1979
Decision
17d
Days
Class 3
Risk

K790988 is an FDA 510(k) clearance for the MODEL 6971 W/ DBS WIRE. 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 June 11, 1979 after a review of 17 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 K790988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1979
Decision Date June 11, 1979
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 K790988.
MEDTRONIC MODELS 69914/699OU
K791667 · Medtronic Vascular · Sep 1979
MODELS UL-804 AND BL-801 UNIPOLAR LEADS
K791552 · Pacesetter Systems · Sep 1979
MEDTRONIC MODEL 6957
K790429 · Medtronic Vascular · Jul 1979
LEADS, IMPLANTABLE CARDIAC PACEMAKERS
K782018 · Oscor, Inc. · Jun 1979
ENDOCARDIAL PACING LEAD, MODEL 476-01
K790548 · Intermedics, Inc. · Jun 1979
MEDTRONIC MODELS 6907/6901
K790766 · Medtronic Vascular · May 1979