510(k) K982220

MODEL 2872 BIPOLAR LEAD ADAPTOR KIT by Medtronic Vascular — Product Code DTD

K982220 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODEL 2872 BIPOLAR LEAD ADAPTOR KIT". The FDA issued a decision of ST on October 15, 1998. 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
October 15, 1998
Date Received
June 24, 1998
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