FDA 510(k) Application Details - K000313

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K000313
Device Name	Introducer, Catheter
Applicant	XENTEK MEDICAL, INC. 6136 FM 1616 ATHENS, TX 75751 US Other 510(k) Applications for this Company
Contact	JIM EDDINGS 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	02/01/2000
Decision Date	06/16/2000
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