Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K210655
Device Classification Name
More FDA Info for this Device
510(K) Number
K210655
Device Name
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
Applicant
Innovative Health, LLC.
1435 North Hayden Road, Suite 100
Scottsdale, AZ 85257 US
Other 510(k) Applications for this Company
Contact
Rick Ferreira
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/04/2021
Decision Date
05/25/2022
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