Kossel Medtech (Suzhou) Co., Ltd.

FDA Regulatory Profile

Kossel Medtech (Suzhou) Co., Ltd. appears in FDA public data with 0 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 16, 2026.

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K254212NC PTA Balloon Dilatation CatheterSeptember 16, 2026
K231402HP PTA Balloon Dilatation CatheterDecember 20, 2023
K221245PTA Balloon Dilatation CatheterDecember 14, 2022
K211349Selebrek PTCA Balloon Dilatation CatheterJanuary 7, 2022
K211393Selethru(TM) NC PTCA Balloon Dilatation CatheterJuly 2, 2021
K182699Selethru PTCA Balloon Dilatation CatheterNovember 26, 2018