FDA 510(k) Application Details - K212988

Device Classification Name	Device, Percutaneous Retrieval   More FDA Info for this Device
510(K) Number	K212988
Device Name	Device, Percutaneous Retrieval
Applicant	Onocor Vascular LLC 808 General Sterling Drive West Chester, PA 19382 US Other 510(k) Applications for this Company
Contact	Tiffini Wittwer Other 510(k) Applications for this Contact
Regulation Number	870.5150   More FDA Info for this Regulation Number
Classification Product Code	MMX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2021
Decision Date	05/23/2022
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