FDA 510(k) Application Details - K120533

Device Classification Name	More FDA Info for this Device
510(K) Number	K120533
Device Name	BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
Applicant	BRIDGEPOINT MEDICAL 13355 10TH AVE N, SUITE #110 PLYMOUTH, MN 55441 US Other 510(k) Applications for this Company
Contact	JILL MUNSINGER 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	02/22/2012
Decision Date	05/22/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review