K250292 is an FDA 510(k) clearance for the OSPREY Midline Closed IV Catheter System (OspreyEDC-F20). This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Skydance Vascular, Inc. (Pleasant Grove, US). The FDA issued a Cleared decision on May 2, 2025, 91 days after receiving the submission on January 31, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K250292 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2025 |
| Decision Date | May 02, 2025 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ - Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |