K241740
- 510(k) number
- K241740
- Device name
- Finesse Injectable PTA Balloon Dilatation Catheter
- Applicant
- Summa Therapeutics MA · US
- Product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Decision date
- 2024-07-16
- Date received
- 2024-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K241740.pdf
Official FDA record: K241740
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.