Catheter, Balloon Type

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Zhejiang and Jiangsu: 4 hold an FDA registration.

Boen Healthcare Co., Ltd. Jiangsu
Huzhou Junda Industry Co., Ltd. Zhejiang, contract manufacturer
Hangzhou Fushan Medical Appliance Co., Ltd. Zhejiang, contract manufacturer
Zhejiang Mediunion Healthcare Group Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code GBA?

Catheter, Balloon Type is FDA product code GBA, Class 1, 21 CFR 878.4200.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2013. None was by a company in China. The root cause the FDA records most often is Packaging (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Catheter, Balloon Type

Symmetry Surgical®

Guide, Van Buren Catheter, Curved, Size 8

Catheter, Balloon Type

Goben

Closed Wound Drainage System, Silicone Drainage Kit 100ml Bulb Reservoir, Flat Drain 10mm, with Perforation, Sterile

Catheter, Balloon Type

Pneumatic Inflator

Catalogue number M00553200, listed by Boston Scientific Corporation, United States, under Catheter, Balloon Type. 4 manufacturers in China are registered for this product code.

Catheter, Balloon Type