Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011175548

FEI Number

3011175548

Entity Name

Atrium Medical Corporation

City/State/Country

Merrimack, NH, US

Establishment Address

40 Continental Blvd, Merrimack, NH 03054, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ATRIUM MEDICAL CORPORATION (Owner Number: 1219977)

Owner / Operator Contact Address

40 Continental Blvd., --, Merrimack, NH 03054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Advanta VXT Vascular Graft Flixene Vascular Grafts with GW Atrium Express Chest Drain Single Collection Dry Suction Dry Seal Atrium Oasis Dry Suction Water Seal Chest Drain Chest Drain Accessories (Connectors, Suction Bulbs, Suction Connectors and Tube Pack) Atrium Oasis Chest Drain Infant/Pediatric Collection Dry Suction Water Seal Atrium Express Mini 500 Chest Drain Single Collection Dry Seal Advanta VXT Vascular Graft Flixene Vascular Graft Advanta VXT Graft Express BRU Chest Drain Ocean BRU Chest Drain Oasis BRU Chest Drain Thoracic catheters PVC and Firm Flixene Grafts Silicone Thoracic Catheters iCast Covered Stent System Vascular Graft Tunneling Instrumentation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2011-07-06
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2009-01-05
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	1993-02-10
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2025-06-17
DYF	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter	Cardiovascular	Class 2	870.3450	2025-06-17
DYF	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter	Cardiovascular	Class 2	870.3450	2011-07-06
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2023-05-18
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2011-07-06
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2010-06-07
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2015-01-08
PRL	Iliac Covered Stent, Arterial	Unknown	Class 3	N/A	2023-05-18
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2011-04-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ATRIUM MEDICAL CORPORATION

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
K962639	Impra, Inc.	IMPRA CARBOFLO EPTFE VASCULAR GRAFT	1996-10-03
K881350	Stryker Corp.	CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM	1988-09-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Z-0020-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132
Z-0024-2025	Atrium Medical Corporation	3	iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Z-0036-2026	W L Gore & Associates, Inc.	2	GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011175548. Last updated year: 2026. Please use registration number 3011175548 when referencing this establishment in official correspondence.