SUMMA THERAPEUTICS, LLC

FDA Device Registration & Listing · Allston, MA, US · Registration 3027395815

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027395815
FEI Number
3027395815
Entity Name
SUMMA THERAPEUTICS, LLC
City/State/Country
Allston, MA, US
Establishment Address
119 Braintree St Ste 508, Allston, MA 02134, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Summa Therapeutics, LLC (Owner Number: 10088115)
Owner / Operator Contact Address
119 Braintree St Ste 508, Boston, MA 02134, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230263
PMA Number
N/A

All Registered Proprietary Names

Finesse Injectable PTA Balloon Dilatation Catheter Finesse™ Injectable PTA Balloon Dilatation Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2024-07-22
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2024-07-22
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-05-27

Official Correspondent

Timothy Murphy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Summa Therapeutics, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K171251 Creagh Medical 014 Hydrophilic Coated PTA Balloon Dilatation Catheter 2017-09-08
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K252512 ABBOTT MEDICAL Armada™ 14 NC PTA Catheter 2026-02-13
K142654 Covidien, LLC Fortrex 0.035 OTW PTA Balloon Catheter 2014-10-28
K202800 Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) Pacific Plus PTA Catheter 2020-11-18

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027395815. Last updated year: 2026. Please use registration number 3027395815 when referencing this establishment in official correspondence.
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