Data / Medical devices / United States / Summa Therapeutics, LLC
Summa Therapeutics, LLC: FDA-registered device maker in Allston, MA, United States, 2 510(k) clearances
Summa Therapeutics, LLC is registered with the FDA (registration 3027395815) in Allston, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 16, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027395815
- Address
- 119 Braintree St Ste 508, Allston, MA, United States, 02134
- Owner or operator
- Summa Therapeutics, LLC (10088115)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 27, 2023
- Registered through
- 2026
- Brand names listed
- Finesse Injectable PTA Balloon Dilatation Catheter, Finesse Injectable PTA Balloon Dilatation Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 16, 2024 | K241740 | Finesse Injectable PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | Summa Therapeutics | accessdata.fda.gov |
| May 26, 2023 | K230263 | Finesse Injectable PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | Summa Therapeutics, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 21, 2025 | 98493 | Class II | Ongoing | 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 angiopl | Potential for the balloon in the device to not meet burst specifications. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheter, Continuous Flush
Updated March 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.