Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K220773
Device Classification Name
Syringe, Balloon Inflation
More FDA Info for this Device
510(K) Number
K220773
Device Name
Syringe, Balloon Inflation
Applicant
Medtronic Vascular
37A Cherry Hill Drive
Danvers, MA 01923 US
Other 510(k) Applications for this Company
Contact
Nikita Ciandra Vaz
Other 510(k) Applications for this Contact
Regulation Number
870.1650
More FDA Info for this Regulation Number
Classification Product Code
MAV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/16/2022
Decision Date
04/13/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact