K223018 is an FDA 510(k) clearance for the OSPREY PERIPHERAL IV Catheter System. 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 April 14, 2023, 197 days after receiving the submission on September 29, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K223018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2022 |
| Decision Date | April 14, 2023 |
| Days to Decision | 197 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 |