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510(k) K242763

JetCan® Pro Safety Huber Needle by Pfm Medical, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2025
Date Received
September 12, 2024
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

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  • K113354 — VETA PERITONEAL DIALYSIS CATHETER (March 13, 2012)
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  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)
  • K242692 — SteadiSet Infusion Set (May 9, 2025)
  • K243529 — Solution Administration Sets (March 14, 2025)