510(k) K911302

MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT by Medtronic Vascular — Product Code DTD

K911302 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT". The FDA issued a decision of Substantially Equivalent on July 30, 1991. 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
July 30, 1991
Date Received
March 25, 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