FDA 510(k) Application Details - K000366

Device Classification Name	Stylet, Catheter   More FDA Info for this Device
510(K) Number	K000366
Device Name	Stylet, Catheter
Applicant	ACCUFIX RESEARCH INSTITUTE 12503 E. EUCLID DR. # 20 ENGLEWOOD, CO 80111 US Other 510(k) Applications for this Company
Contact	MICHAEL J ANDREWS Other 510(k) Applications for this Contact
Regulation Number	870.1380   More FDA Info for this Regulation Number
Classification Product Code	DRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2000
Decision Date	04/14/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review