Cleared Traditional

K790766 - MEDTRONIC MODELS 6907/6901 (FDA 510(k) Clearance)

May 1979
Decision
36d
Days
Class 3
Risk

K790766 is an FDA 510(k) clearance for the MEDTRONIC MODELS 6907/6901. This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on May 25, 1979, 36 days after receiving the submission on April 19, 1979.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K790766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1979
Decision Date May 25, 1979
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code DTB — Permanent Pacemaker Electrode
Device Class Class III - Premarket Approval
CFR Regulation 21 CFR 870.3680