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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K251375
Device Name PuraCath Firefly Needleless Connector IT (9005)
Applicant
Puracath Medical, Inc.
37600 Central Court
Suite 210
Newark,  CA  94560
Applicant Contact Julia Rasooly
Correspondent
Puracath Medical, Inc.
37600 Central Court
Suite 210
Newark,  CA  94560
Correspondent Contact Julia Rasooly
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/02/2025
Decision Date 02/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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