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510(k) K250292

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) by Skydance Vascular, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2025
Date Received
January 31, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Skydance Vascular, Inc.

  • K231626 — OSPREY Closed IV Catheter System (OspreyV2) (August 31, 2023)
  • K223018 — OSPREY PERIPHERAL IV Catheter System (April 14, 2023)

Other clearances for product code FOZ

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  • K251422 — BD Saf-T-Intima™ Subcutaneous Catheter System (October 8, 2025)
  • K243403 — BD Nexiva™ Closed IV Catheter System (July 25, 2025)
  • K251155 — BD Cathena™ Safety IV Catheter (July 11, 2025)
  • K251654 — BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV (June 27, 2025)
  • K250682 — BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed (June 3, 2025)
  • K243105 — Ruby Intravascular Catheter (May 16, 2025)
  • K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual (March 27, 2025)
  • K243599 — Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (March 14, 2025)