SUMMA THERAPEUTICS, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1704-2026 | Class II | Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Cata | July 21, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241740 | Finesse Injectable PTA Balloon Dilatation Catheter | July 16, 2024 |
| K230263 | Finesse Injectable PTA Balloon Dilatation Catheter | May 26, 2023 |
| K150452 | ComboCath OTW PTA Dilatation Catheter | August 13, 2015 |