Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K162901
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K162901
Device Name
Catheter, Thrombus Retriever
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
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
10/17/2016
Decision Date
04/20/2017
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact