FDA 510(k)

VedDilator ^TM (3-Stage Balloon Dilation Catheter)

Número K: K232245 · 2024-02-15

RequerenteJiangsu Vedkang Medical Science and Technology Co., Ltd.

Data da decisão2024-02-15

Código do produtoFGE

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

VedDilator ^TM (3-Stage Balloon Dilation Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Vedkang Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K232245. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VedDilator ^TM (3-Stage Balloon Dilation Catheter)?

VedDilator ^TM (3-Stage Balloon Dilation Catheter) is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Jiangsu Vedkang Medical Science and Technology Co., Ltd.. The 510(k) number is K232245.

When did VedDilator ^TM (3-Stage Balloon Dilation Catheter) receive FDA 510(k) clearance?

VedDilator ^TM (3-Stage Balloon Dilation Catheter) received FDA 510(k) clearance on 2024-02-15, under 510(k) number K232245.

Who is the listed applicant for VedDilator ^TM (3-Stage Balloon Dilation Catheter)?

The FDA 510(k) record lists Jiangsu Vedkang Medical Science and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VedDilator ^TM (3-Stage Balloon Dilation Catheter)?

The FDA product code for VedDilator ^TM (3-Stage Balloon Dilation Catheter) is FGE.

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