ClearanceBrief
510(k) K232752 ยท GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

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)

ApplicantJiangsu Vedkang Medical Science and Technology Co., Ltd., Changzhou, CN
DecisionSubstantially Equivalent, Feb 26, 2024
ReceivedSep 8, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K232752

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.