FDA 510(k) Application Details - K211654

Device Classification Name	Catheter, Thrombus Retriever   More FDA Info for this Device
510(K) Number	K211654
Device Name	Catheter, Thrombus Retriever
Applicant	Penumbra, Inc. One Penumbra Place Alameda, CA 95132 US Other 510(k) Applications for this Company
Contact	Nikita Patel Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	NRY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2021
Decision Date	08/16/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review