LLA - BEUDAMED

B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.

FDA Enforcement

Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OLYMPUS MEDICAL SYSTEMS CORP.

Manufacturer

🇯🇵 Japan·1 Importer·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Asahi Kasei Medical Co., Ltd.

Manufacturer

🇯🇵 Japan·10 Basic UDI-DIs·27 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Shimadzu Corporation

Manufacturer

🇯🇵 Japan·348 Basic UDI-DIs·361 Devices·2 Importers·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Tosoh Corporation

Manufacturer

🇯🇵 Japan·388 Basic UDI-DIs·414 Devices·1 Importer·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Terumo Corporation

Manufacturer

🇯🇵 Japan·4 Importers·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

TOP Corporation

Manufacturer

🇯🇵 Japan·39 Basic UDI-DIs·97 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH