510(k) K230263 · LIT Catheter, Angioplasty, Peripheral, Transluminal
Finesse Injectable PTA Balloon Dilatation Catheter
| Applicant | Summa Therapeutics, LLC, Providence RI, US |
| Decision | Substantially Equivalent, May 26, 2023 |
| Received | Jan 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2026 | SUMMA THERAPEUTICS, LLC Brand Name: Finesse BTK Multicath
Product Name: Injectable Angioplasty Balloon Catheter
Model/Catalog Number: FS252251502
Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wir Open, Classified |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.