| Device Classification Name |
Injector And Syringe, Angiographic
|
|---|
| 510(k) Number |
K252652 |
|---|
| Device Name |
Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr |
|---|
| Applicant |
| Fortis Biosolutions Company Limited |
| # 121, Ln. 215, Gaoyang S. Rd. |
| Longtan Dist., |
|
Taoyuan City,
TW
325004
|
|
| Applicant Contact |
Sharon Au |
| Correspondent |
| Fortis Biosolutions Company Limited |
| # 121, Ln. 215, Gaoyang S. Rd. |
| Longtan Dist., |
|
Taoyuan City,
TW
325004
|
|
| Correspondent Contact |
Sharon Au |
| Regulation Number | 870.1650 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/22/2025 |
|---|
| Decision Date | 05/14/2026 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Cardiovascular
|
|---|
| 510k Review Panel |
General Hospital
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
|
