510(k) K000210

MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT by Medtronic Vascular — Product Code DTD

K000210 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT". The FDA issued a decision of ST on February 23, 2000. 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
ST ()
Decision Date
February 23, 2000
Date Received
January 24, 2000
Clearance Type
Special
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