510(k) K852236

MEDTRONIC MODEL 5867-1A by Medtronic Vascular — Product Code KFJ

K852236 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC MODEL 5867-1A". The FDA issued a decision of Substantially Equivalent on July 11, 1985. The device falls under product code KFJ (Materials, Repair Or Replacement, Pacemaker), a Class III device regulated under 21 CFR 870.3710. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1985
Date Received
May 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Materials, Repair Or Replacement, Pacemaker
Device Class
Class III
Regulation Number
870.3710
Review Panel
CV
Submission Type