510(k) K003535

STYLET KIT, MODELS 6254,6282,6293 by Medtronic Vascular — Product Code DRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2001
Date Received
November 16, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Catheter
Device Class
Class II
Regulation Number
870.1380
Review Panel
CV
Submission Type