510(k) K880738

MODEL 2331T PATIENT PROGRAMMER by Medtronic Vascular — Product Code KRG

K880738 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODEL 2331T PATIENT PROGRAMMER". The FDA issued a decision of Substantially Equivalent on November 17, 1988. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1988
Date Received
February 24, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Pacemaker
Device Class
Class III
Regulation Number
870.3700
Review Panel
CV
Submission Type