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FDA 510(k) Application Details - K222568
Device Classification Name
Catheter, Ultrasound, Intravascular
More FDA Info for this Device
510(K) Number
K222568
Device Name
Catheter, Ultrasound, Intravascular
Applicant
Boston Scientific Corporation
1 Scimed Place
Maple Grove, MN 55311 US
Other 510(k) Applications for this Company
Contact
Cassie Clark
Other 510(k) Applications for this Contact
Regulation Number
870.1200
More FDA Info for this Regulation Number
Classification Product Code
OBJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/24/2022
Decision Date
09/23/2022
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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