Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K221294
Device Classification Name
Catheter, Intravascular Occluding, Temporary
More FDA Info for this Device
510(K) Number
K221294
Device Name
Catheter, Intravascular Occluding, Temporary
Applicant
Abiomed Inc.
22 Cherry Hill Drive
Danvers, MA 01923 US
Other 510(k) Applications for this Company
Contact
Ken Ryder
Other 510(k) Applications for this Contact
Regulation Number
870.4450
More FDA Info for this Regulation Number
Classification Product Code
MJN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/04/2022
Decision Date
06/30/2023
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact