FDA 510(k) Application Details - K112887

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K112887
Device Name	Introducer, Catheter
Applicant	UPSTREAM PERIPHERAL TECHNOLOGIES 1835 MARKET STREET 29TH FLOOR PHILADELPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	JANICE M HOGAN Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2011
Decision Date	03/21/2012
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