FDA 510(k) Application Details - K220683

Device Classification Name	More FDA Info for this Device
510(K) Number	K220683
Device Name	INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
Applicant	Penumbra, Inc. One Penumbra Place Alameda, CA 94502 US Other 510(k) Applications for this Company
Contact	Sindokht (Sisi) Soltanzadeh Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/2022
Decision Date	10/04/2022
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review