Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020368143

FEI Number

3020368143

Entity Name

AXON THERAPIES, INC.

City/State/Country

New York, NY, US

Establishment Address

345 Park Ave S, New York, NY 10010, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Axon Therapies, Inc. (Owner Number: 10084644)

Owner / Operator Contact Address

2326 Walsh Ave, Santa Clara, CA 95051, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Axon Delivery System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEX	Cardiovascular Catheter Sheath Introducer Kit	Cardiovascular	Class 2	870.1340	2022-03-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Axon Therapies, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020368143. Last updated year: 2026. Please use registration number 3020368143 when referencing this establishment in official correspondence.