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FDA 510(k) Application Details - K221464
Device Classification Name
System, Catheter Control, Steerable
More FDA Info for this Device
510(K) Number
K221464
Device Name
System, Catheter Control, Steerable
Applicant
Corindus, Inc.
309 Waverley Oaks Road, Suite 105
Waltham, MA 02452 US
Other 510(k) Applications for this Company
Contact
Robert Lavado
Other 510(k) Applications for this Contact
Regulation Number
870.1290
More FDA Info for this Regulation Number
Classification Product Code
DXX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/19/2022
Decision Date
07/27/2022
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
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