FDA 510(k) Application Details - K081394

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K081394
Device Name	Introducer, Catheter
Applicant	ENPATH MEDICAL, INC. 2300 BERKSHIRE LANE NORTH MINNEAPOLIS, MN 55441 US Other 510(k) Applications for this Company
Contact	SHANNON SPRINGER 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	05/19/2008
Decision Date	09/15/2008
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