Data / Medical devices / China / Brosmed Medical Co.,ltd
Brosmed Medical Co.,ltd: FDA-registered device maker in Dongguan Guangdong, China, 10 510(k) clearances
Brosmed Medical Co.,ltd is registered with the FDA (registration 3010391265) in Dongguan Guangdong, China. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 27, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010391265
- Address
- 15th Building, SMEs Venture Park SongShan Lake Hi-Tech Industrial Development Zone, Dongguan Guangdong, China, 523808
- Owner or operator
- Brosmed Medical Co.,Ltd (10044695)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- September 16, 2014
- Registered through
- 2026
- Brand names listed
- Aperi NC Balloon Dilatation Catheter, Aperi NC Balloon Dilatation Cathter, Aperi SC Balloon Dilatation Catheter, Apollo Balloon Dilatation Catheter, Artimes pro Balloon Dilatation Cathter, Balloon Inflation Device, Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters, Polux, Minerva, and Atropos PTA Balloon Dilatation Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous, Cutting/Scoring | PNO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Balloon Inflation, Exempt | PTM | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 27, 2025 | 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 | Brosmed Medical Co., Ltd. | accessdata.fda.gov |
| October 22, 2024 | K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | PNO | Substantially Equivalent | Brosmed Medical Co., Ltd. | accessdata.fda.gov |
| April 11, 2023 | K230705 | POT PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | Brosmed Medical Co., Ltd. | accessdata.fda.gov |
| July 19, 2022 | K212215 | Tiche PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | Brosmed Medical Co., Ltd. | accessdata.fda.gov |
| April 14, 2021 | K203390 | Artimes pro Balloon Dilatation Catheter | LOX | Substantially Equivalent | Brosmed Medical Co., Ltd. | accessdata.fda.gov |
| December 13, 2016 | K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | Brosmed Medical Co., Ltd. | accessdata.fda.gov |
| August 8, 2016 | K153742 | Apollo Balloon Dilatation Catheter | LOX | Substantially Equivalent | Brosmed Medical Co., Ltd. | accessdata.fda.gov |
| July 29, 2016 | K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | Brosmed Medical Co., Ltd. | accessdata.fda.gov |
| September 19, 2014 | K133852 | APOLLO BALLOON DILATATION CATHETER | LOX | Substantially Equivalent | Brosmed Medical | accessdata.fda.gov |
| September 12, 2014 | K141025 | ARTIMES BALLOON DILATATION CATHETER | LOX | Substantially Equivalent | Brosmed Medical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 14, 2018 | 81973 | Class II | Terminated | 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 obstruc | Incorrect (higher) Rated Burst Pressure information printed on label. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Syringe, Balloon Inflation, Exempt
- All makers of Catheter, Percutaneous, Cutting/Scoring
Updated February 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.