FDA 510(k) Application Details - K210012

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K210012
Device Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant	Natec Medical Ltd. Maeva Centra Building, Silicon Avenue Ebene Business Park Reduit 72201 MU Other 510(k) Applications for this Company
Contact	Roy Devassy Pallippatt Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/2021
Decision Date	07/09/2021
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