Finesse™ Injectable PTA Balloon Dilatation Catheter
FDA 510(k) clearance K230263 · decided 2023-05-26
Clearance details
- K-number
- K230263
- Device name
- Finesse™ Injectable PTA Balloon Dilatation Catheter
- Applicant
- Summa Therapeutics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-01-31
- Decision date
- 2023-05-26
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Providence, RI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Mo recall (Z-1704-2026) | SUMMA THERAPEUTICS, LLC | 2026-03-30 |