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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K231626
Device Name OSPREY Closed IV Catheter System (OspreyV2)
Applicant
Skydance Vascular, Inc.
3058 Millcreek Rd.
Pleasant Grove,  UT  84062
Applicant Contact Scott Pease
Correspondent
Skydance Vascular, Inc.
3058 Millcreek Rd.
Pleasant Grove,  UT  84062
Correspondent Contact Scott Pease
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received06/02/2023
Decision Date 08/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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