BrosMed Medical Co.,Ltd.
Dongguan Guangdong, CN
BROSMED MEDICAL CO.,LTD appears in FDA device records in Dongguan Guangdong, CN. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for BrosMed Medical Co.,Ltd. between 2014 and 2025. The busiest year on record is 2016, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 2 |
| 2016 | 3 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | PNO | Substantially Equivalent | |
| K230705 | POT PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | |
| K212215 | Tiche PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K203390 | Artimes pro Balloon Dilatation Catheter | LOX | Substantially Equivalent | |
| K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K153742 | Apollo Balloon Dilatation Catheter | LOX | Substantially Equivalent | |
| K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K133852 | APOLLO BALLOON DILATATION CATHETER | LOX | Substantially Equivalent | |
| K141025 | ARTIMES BALLOON DILATATION CATHETER | LOX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010391265 | 3010391265 | BROSMED MEDICAL CO.,LTD | 15th Building, SMEs Venture Park, Dongguan Guangdong 523808 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0963-2019 | 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 treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature. | Incorrect (higher) Rated Burst Pressure information printed on label. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain