Cleared Traditional

K843706 - MEDTRONIC 6957

K843706 is the FDA 510(k) clearance for MEDTRONIC 6957 by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K843706 · Medtronic Vascular · Cardiovascular device
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Dec 1984
Decision
97d
Days
Class 3
Risk

K843706 is an FDA 510(k) clearance for the MEDTRONIC 6957. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 27, 1984 after a review of 97 days - within the typical 510(k) review window.

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 K843706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1984
Decision Date December 27, 1984
Days to Decision 97 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
28d faster than avg
Panel avg: 125d · This submission: 97d
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 K843706.
MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN
K844959 · Medtronic Vascular · Jan 1985
MEDTRONIC 6957J
K843707 · Medtronic Vascular · Jan 1985
CORDIS ENCOR ATRIAL LEAD
K811259 · Cordis Corp. · Dec 1984
LIFELINE TLE 476-04
K843393 · Intermedics, Inc. · Sep 1984
LIFELINE TLE 484-02
K843394 · Intermedics, Inc. · Sep 1984
PACING ELECTRODE
K834431 · Pacesetter Systems · Mar 1984