Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K202821
Device Classification Name
More FDA Info for this Device
510(K) Number
K202821
Device Name
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
Applicant
Penumbra, Inc.
One Penumbra Place
Alameda, CA 94502 US
Other 510(k) Applications for this Company
Contact
Michaela Mahl
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
09/24/2020
Decision Date
11/18/2020
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact