510(k) K915724

MODEL 6984M LEAD EXTENDER KIT by Medtronic Vascular — Product Code DTD

K915724 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODEL 6984M LEAD EXTENDER KIT". The FDA issued a decision of Substantially Equivalent on February 18, 1992. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1992
Date Received
December 20, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker Lead Adaptor
Device Class
Class II
Regulation Number
870.3620
Review Panel
CV
Submission Type