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510(k) K203796

Firefly Needleless Connector by Puracath Medical, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2021
Date Received
December 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Puracath Medical, Inc.

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  • K242692 — SteadiSet Infusion Set (May 9, 2025)
  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)