Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011836011

FEI Number

3011836011

Entity Name

CORVIA MEDICAL, INC.

City/State/Country

Tewksbury, MA, US

Establishment Address

1 Highwood Drive, Suite 300, Tewksbury, MA 01876, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Corvia Medical, Inc. (Owner Number: 10055161)

Owner / Operator Contact Address

1 Highwood Drive, Suite 300, Tewksbury, MA 01876, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Corvia Atrial Shunt System / IASD System II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OFK	Percutaneous Atrial Catheter Kit	Cardiovascular	Class 2	870.1250	2017-06-14

Official Correspondent

Katharine Stohlman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Corvia Medical, 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 3011836011. Last updated year: 2026. Please use registration number 3011836011 when referencing this establishment in official correspondence.