FDA 510(k) Application Details - K101777

Device Classification Name	More FDA Info for this Device
510(K) Number	K101777
Device Name	PIONEER PLUS CATHETER, MODEL PLUS 120
Applicant	MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa, CA 95403 US Other 510(k) Applications for this Company
Contact	LUCINDA L FOX Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2010
Decision Date	07/23/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review