510(k) K896632

MEDTRONIC MODEL 5401B TEST CABLE by Medtronic Vascular — Product Code DTC

K896632 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC MODEL 5401B TEST CABLE". The FDA issued a decision of Substantially Equivalent on December 13, 1989. 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
December 13, 1989
Date Received
November 22, 1989
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