FDA 510(k) Application Details - K202226

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K202226
Device Name	Introducer, Catheter
Applicant	Keystone Heart, Ltd. 15 Halamish Street, PO Box 3170 Caesaria 3088900 IL Other 510(k) Applications for this Company
Contact	Jaime Sarabia 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	08/07/2020
Decision Date	12/15/2020
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