510(k) K932884

MINIX/MINIX ST PULSE GENERATORS by Medtronic Vascular — Product Code DXY

K932884 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MINIX/MINIX ST PULSE GENERATORS". The FDA issued a decision of SESP on May 2, 1994. 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
SESP ()
Decision Date
May 2, 1994
Date Received
June 14, 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