FDA 510(k) Application Details - K111963

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K111963
Device Name	Catheter, Percutaneous
Applicant	BRIDGEPOINT MEDICAL 2800 CAMPUS DR STE 50 PLYMOUTH, MN 55441 US Other 510(k) Applications for this Company
Contact	JILL MUNSINGER Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2011
Decision Date	08/10/2011
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