510(k) K791667

MEDTRONIC MODELS 69914/699OU by Medtronic Vascular — Product Code DTB

K791667 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC MODELS 69914/699OU". The FDA issued a decision of Substantially Equivalent on September 7, 1979. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1979
Date Received
August 28, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Permanent Pacemaker Electrode
Device Class
Class III
Regulation Number
870.3680
Review Panel
CV
Submission Type