Kossel Medtech (Suzhou) Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: HP PTA Balloon Dilatation Catheter, PTA Balloon Dilatation Catheter, Selebrek PTCA Balloon Dilatation Catheter
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kossel Medtech (Suzhou) Co., Ltd. Cardiovascular ✕
5 devices
Cleared
Dec 20, 2023
HP PTA Balloon Dilatation Catheter
Cardiovascular
219d
Cleared
Dec 14, 2022
PTA Balloon Dilatation Catheter
Cardiovascular
226d
Cleared
Jan 07, 2022
Selebrek PTCA Balloon Dilatation Catheter
Cardiovascular
249d
Cleared
Jul 02, 2021
Selethru(TM) NC PTCA Balloon Dilatation Catheter
Cardiovascular
58d
Cleared
Nov 26, 2018
Selethru PTCA Balloon Dilatation Catheter
Cardiovascular
60d