OSPREY Closed IV Catheter System (OspreyV2)
Skydance Vascular, Inc.
SKYDANCE VASCULAR, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3022054170 | 3022054170 | SKYDANCE VASCULAR, INC. | 1 | N | 2026-01-01 | 3058 Millcreek Rd. Pleasant Grove UT US 84062 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 317271 | 1941278769 | K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | FOZ | 2025-05-02 |
| 317271 | 1960496431 | K231626 | OSPREY Closed IV Catheter System (OspreyV2) | FOZ | 2023-08-31 |
| 317271 | 1009242238 | K223018 | OSPREY PERIPHERAL IV Catheter System | FOZ | 2023-04-14 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FOZ | 3 | 2025-05-02 |
PMN#
OSPREY PERIPHERAL IV Catheter System
Skydance Vascular, Inc.