510(k) K812262

MEDTRONIC A-V PACING SYSTEM ANALYZER by Medtronic Vascular — Product Code DTC

K812262 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC A-V PACING SYSTEM ANALYZER". The FDA issued a decision of Substantially Equivalent on June 17, 1982. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1982
Date Received
August 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function
Device Class
Class II
Regulation Number
870.3630
Review Panel
CV
Submission Type