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FDA 510(k)

VedDilator ^TM (3-Stage Balloon Dilation Catheter)

K-Number: K232245 · 2024-02-15

ApplicantJiangsu Vedkang Medical Science and Technology Co., Ltd.
Decision Date2024-02-15
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd.. The 510(k) number is K232245.

When was VedDilator ^TM (3-Stage Balloon Dilation Catheter) approved by the FDA?

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

What company makes VedDilator ^TM (3-Stage Balloon Dilation Catheter)?

VedDilator ^TM (3-Stage Balloon Dilation Catheter) is manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd..

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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Other Devices by Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K220089Disposable Polyp Snare K213914Injection Needle K230598Stone Extraction Baskets K222146Disposable Endoscopic Hemoclip K232825Disposable Sphincterotome K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)

View all 7 devices →

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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