FDA 510(k) Application Details - K170298

Device Classification Name	Stylet, Catheter   More FDA Info for this Device
510(K) Number	K170298
Device Name	Stylet, Catheter
Applicant	Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 US Other 510(k) Applications for this Company
Contact	Steven Lawrie 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	01/31/2017
Decision Date	10/18/2017
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