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FDA 510(k) Application Details - K203796
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K203796
Device Name
Set, Administration, Intravascular
Applicant
PuraCath Medical, Inc
37600 Central Court, Suite 210
Newark, CA 94560 US
Other 510(k) Applications for this Company
Contact
Julia Rasooly
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/28/2020
Decision Date
07/30/2021
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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