Facility

SUMMA THERAPEUTICS, LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst OAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3027395815
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	119 Braintree St Ste 508 Allston, MA, US 02134
Registration status	Active · expires 2026
Parent company	Summa Therapeutics, LLC (owner-operator 10088115)
Brand names	Finesse Injectable PTA Balloon Dilatation Catheter

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Catheter, Angioplasty, Peripheral, Transluminal
Product code LIT (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1250
Catheter, Continuous Flush
Product code KRA (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1210

Recalls & enforcement

Class IIOngoing2025-07-21
Potential for the balloon in the device to not meet burst specifications.

FDA inspections (1)

NAI2026-02-26
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Summa Therapeutics, LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SUMMA THERAPEUTICS, LLC (FEI 3027395815) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3027395815-summa-therapeutics-llc/

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