COBRA-OS™ - The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
2023-08-25
FRONT LINE MEDICAL TECHNOLOGIES INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3018565086 | 3018565086 | FRONT LINE MEDICAL TECHNOLOGIES INC. | 1 | N | 2026-01-01 | 2 Bloor Street West, Suite 700 Toronto Ontario CA M4W 3E2 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 300380 | 1735864822 | K201652 | COBRA-OS Kit | MJN | 2021-02-22 |
| 300380 | 1514301591 | K073035 | PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS | DRE | 2007-11-20 |
Product Codes Associated With Registrations#
GUDID#
Syringe, 10 mL - The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon.The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
2023-08-25
COBRA-OS™ - The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
2022-02-09
Syringe, 10 mL - The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon.The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
2022-02-09
COBRA-OS™ - The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
2022-01-28
COBRA-OS® - The COBRA-OS® is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
2024-03-22
Syringe, 10 mL - The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon.
2024-03-22
COBRA-OS™ - The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
2023-08-25