Total clearances
2
2023-05-26 → 2024-07-16
Name variants in FDA filings: Summa Therapeutics, LLC / Summa Therapeutics
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| LIT |
Catheter, Angioplasty, Peripheral, Transluminal |
Class II |
Cardiovascular |
2 |
2024-07-16 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2025-07-21 |
Class II
|
Ongoing |
Z-1704-2026 |
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251… |
— |
Potential for the balloon in the device to not meet burst specifications. |
Filings
All 510(k) clearances (2)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2024-07-16 |
K241740 |
Finesse Injectable PTA Balloon Dilatation Catheter |
LIT |
Class II |
Cardiovascular |
| 2023-05-26 |
K230263 |
Finesse Injectable PTA Balloon Dilatation Catheter |
LIT |
Class II |
Cardiovascular |