510(k) K231626
K231626 is an FDA 510(k) premarket notification submitted by Skydance Vascular, Inc. for the device "OSPREY Closed IV Catheter System (OspreyV2)". The FDA issued a decision of Substantially Equivalent on August 31, 2023. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Skydance Vascular, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2023
- Date Received
- June 2, 2023
- 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