510(k) K031274

MODEL 5071 MYOCARDIAL PACING LEAD by Medtronic Vascular — Product Code DTB

K031274 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODEL 5071 MYOCARDIAL PACING LEAD". The FDA issued a decision of ST on May 22, 2003. 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
ST ()
Decision Date
May 22, 2003
Date Received
April 22, 2003
Clearance Type
Special
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