Company ยท CN
Brosmed Medical Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2025. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2025 | K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Brosmed Medical Co., Ltd., CN | LIT |
| Oct 22, 2024 | K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter Brosmed Medical Co., Ltd., CN | PNO |
| Apr 11, 2023 | K230705 | POT PTCA Balloon Dilatation Catheter Brosmed Medical Co., Ltd., CN | LOX |
| Jul 19, 2022 | K212215 | Tiche PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd., CN | LIT |
| Apr 14, 2021 | K203390 | Artimes pro Balloon Dilatation Catheter Brosmed Medical Co., Ltd., CN | LOX |
| Dec 13, 2016 | K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd., CN | LIT |
| Aug 8, 2016 | K153742 | Apollo Balloon Dilatation Catheter Brosmed Medical Co., Ltd., CN | LOX |
| Jul 29, 2016 | K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd., CN | LIT |
| Sep 19, 2014 | K133852 | APOLLO BALLOON DILATATION CATHETER Brosmed Medical, CN | LOX |
| Sep 12, 2014 | K141025 | ARTIMES BALLOON DILATATION CATHETER Brosmed Medical, CN | LOX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2018 | BrosMed Medical Co.,Ltd. Hermes NC PTA Balloon Dilatation Catheter
The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the Terminated |
LIT | K160941 |