Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Summa Therapeutics with 3 510(k) clearances and 1 device recall. The most recent is a device recall dated Jul 21, 2025: Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 21, 2025 | Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product DescripClass II · Potential for the balloon in the device to not meet burst specifications. | Device recalls |
| Jul 16, 2024 | Finesse Injectable™ PTA Balloon Dilatation CatheterK241740 · LIT | 510(k) clearances |
| May 26, 2023 | Finesse™ Injectable PTA Balloon Dilatation CatheterK230263 · LIT | 510(k) clearances |
| Aug 13, 2015 | ComboCath OTW PTA Dilatation CatheterK150452 · LIT | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
