TT MEDICAL USA, LLC

FDA Device Registration & Listing · Duxbury, MA, US · Registration 3030421123

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
3030421123
FEI Number
3030421123
Entity Name
TT MEDICAL USA, LLC
City/State/Country
Duxbury, MA, US
Establishment Address
62 Strawberry Ln, Duxbury, MA 02332, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
TT Medical USA, LLC (Owner Number: 10090008)
Owner / Operator Contact Address
62 Strawberry Lane, Duxbury, MA 02332, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K230374
PMA Number
N/A

All Registered Proprietary Names

VesPenetrator VesTraveler VexPander

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2025-12-10

Official Correspondent

Edward Kislauskis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TT Medical USA, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030421123. Last updated year: 2026. Please use registration number 3030421123 when referencing this establishment in official correspondence.
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