đź“‹ FDA Reference
NC PTA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd.
FDA Clearance Information
Pathway
510K
Number
K254212 ↗
Decision Date
September 16, 2026
Product Code
LIT
Device Class
Class 2
Evidence
0 studies
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It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.