OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
Skydance Vascular, Inc. · General Hospital
Open FDA's page for this record- Third party flag
- N
- City
- Pleasant Grove
- Advisory committee description
- General Hospital
- Address 1
- 3058 Millcreek Rd.
- Statement or summary
- Summary
- Product code
- FOZ
- Zip code
- 84062
- Applicant
- Skydance Vascular, Inc.
- Decision date
- 2025-05-02
- Decision code
- SESE
- Country code
- US
- Device name
- OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
- Advisory committee
- HO
- Contact
- Scott Pease
- K number
- K250292
- State
- UT
- Date received
- 2025-01-31
- Review advisory committee
- HO
- Postal code
- 84062
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Medical specialty description
- General Hospital
- Regulation number
- 880.5200
- Device class
- 2
- Registration number
- 3005246939, 3004784537, 3013557562, 3006425876, 1410248, 1319211, 3010131137, 3013162291, 3013517171, 3004122598, 8010026, 1319639, 2032112, 3010055973, 1220477, 1220905, 9611446, 1054241, 3003674698, 1721686, 3010754844, 3013298431, 9680794, 3008496528, 2245270, 3009750712, 3035111606, 3007616112, 9610849, 9610847, 3006260740, 1644312, 3002807314, 3033536319, 9616088, 3001124136, 1417592, 2320762, 2025816, 1018470 +161 more
- FEI number
- 3005246939, 3004784537, 3013557562, 3006425876, 1410248, 1319211, 3010131137, 3013162291, 3013517171, 3003058448, 3004122598, 2828, 3001236905, 3010055973, 1000132332, 1220477, 1220905, 3005747797, 1000160458, 3003674698, 3008397795, 1721686, 3010754844, 3013298431, 3008496528, 3003205539, 3003752255, 1000138054, 3009750712, 2245270, 3035111606, 3007616112, 3006260740, 3003040625, 3002807314, 3000206435, 3033536319, 1000174591, 3001124136, 1417592 +160 more