510(k) K930770

MEDTRONIC MINIX & MINIX ST PULSE GENERATORS by Medtronic Vascular — Product Code DXY

K930770 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC MINIX & MINIX ST PULSE GENERATORS". The FDA issued a decision of Substantially Equivalent on May 14, 1993. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1993
Date Received
February 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implantable Pacemaker Pulse-Generator
Device Class
Class III
Regulation Number
870.3610
Review Panel
CV
Submission Type