FDA 510(k) Application Details - K193322

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K193322
Device Name	Catheter, Percutaneous
Applicant	Nitiloop Ltd. 1st Tidar Street Pardes Hanna 3701000 IL Other 510(k) Applications for this Company
Contact	Amir Pansky Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2019
Decision Date	04/02/2020
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