FDA 510(k) Application Details - K173423

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K173423
Device Name	Wire, Guide, Catheter
Applicant	Nano4Imaging GmbH Pauwelsstrasse 17 Aachen 52074 DE Other 510(k) Applications for this Company
Contact	Christoph R. Manegold Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2017
Decision Date	11/17/2017
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