Medical Device Manufacturer · CN , Dongguan

Brosmed Medical Co., Ltd. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2016

Recent clearances: Parafleet SC 014 PTA Balloon Dilatation Catheter, Tri-Wedge PTA Scoring Balloon Dilatation Catheter, POT PTCA Balloon Dilatation Catheter

8
Total
8
Cleared
0
Denied

FDA 510(k) Regulatory Record - Brosmed Medical Co., Ltd. Cardiovascular ✕

8 devices
1-8 of 8
Cleared Feb 27, 2025
Parafleet SC 014 PTA Balloon Dilatation Catheter
K243704 · LIT
Cardiovascular · 90d
Cleared Oct 22, 2024
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
K241478 · PNO
Cardiovascular · 151d
Cleared Apr 11, 2023
POT PTCA Balloon Dilatation Catheter
K230705 · LOX
Cardiovascular · 28d
Cleared Jul 19, 2022
Tiche PTA Balloon Dilatation Catheter
K212215 · LIT
Cardiovascular · 369d
Cleared CT Apr 14, 2021
Artimes pro Balloon Dilatation Catheter
K203390 · LOX
Cardiovascular · 147d
Cleared Dec 13, 2016
Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
K160941 · LIT
Cardiovascular · 253d
Cleared Aug 08, 2016
Apollo Balloon Dilatation Catheter
K153742 · LOX
Cardiovascular · 224d
Cleared Jul 29, 2016
Polux , Minerva and Atropos PTA Balloon Dilatation Catheter
K160256 · LIT
Cardiovascular · 179d
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