K232752
- 510(k) number
- K232752
- Device name
- Stone 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)
- Applicant
- Jiangsu Vedkang Medical Science and Technology Co., Ltd. CN
- Product code
- GCA — Biliary Catheter For Stone Removal That May Also All
- Decision date
- 2024-02-26
- Date received
- 2023-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K232752.pdf
Official FDA record: K232752
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.