Summa Therapeutics, LLC
Allston, MA, US
SUMMA THERAPEUTICS, LLC appears in FDA device records in Allston, MA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Summa Therapeutics, LLC between 2015 and 2024. The busiest year on record is 2015, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241740 | Finesse Injectable™ PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K230263 | Finesse™ Injectable PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K150452 | ComboCath OTW PTA Dilatation Catheter | LIT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3027395815 | 3027395815 | SUMMA THERAPEUTICS, LLC | 119 Braintree St Ste 508, Allston, MA 02134 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1704-2026 | 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-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA | Potential for the balloon in the device to not meet burst specifications. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain