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FDA 510(k) Application Details - K223648
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device
510(K) Number
K223648
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
Cook Advanced Technologies
1400 Cumberland Avenue
West Lafayette, IN 47906 US
Other 510(k) Applications for this Company
Contact
Matthew Waninger
Other 510(k) Applications for this Contact
Regulation Number
880.5200
More FDA Info for this Regulation Number
Classification Product Code
FOZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/06/2022
Decision Date
02/03/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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