FDA 510(k) Application Details - K210235

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K210235
Device Name	Wire, Guide, Catheter
Applicant	Volcano Corporation 3721 Valley Centre Drive, Ste 500 San Diego, CA 92130 US Other 510(k) Applications for this Company
Contact	Leilani Taylor 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	01/28/2021
Decision Date	04/15/2021
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