The following data is part of a premarket notification filed by Brosmed Medical Co., Ltd. with the FDA for Artimes Pro Balloon Dilatation Catheter.
| Device ID | K203390 |
| 510k Number | K203390 |
| Device Name: | Artimes Pro Balloon Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | BrosMed Medical Co., Ltd. 15th Building, SMEs Venture Park, Songshan Lake Hi-Tech Development Zone Dongguan, CN 523808 |
| Contact | Wade Zhang |
| Correspondent | Diane Horwitz Eminence Clinical Research Inc. 5 Lake Como Ct. Greenville, SC 29609 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-18 |
| Decision Date | 2021-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06958481412666 | K203390 | 000 |
| 06958481412529 | K203390 | 000 |
| 06958481412536 | K203390 | 000 |
| 06958481412543 | K203390 | 000 |
| 06958481412550 | K203390 | 000 |
| 06958481412567 | K203390 | 000 |
| 06958481412574 | K203390 | 000 |
| 06958481412581 | K203390 | 000 |
| 06958481412598 | K203390 | 000 |
| 06958481412604 | K203390 | 000 |
| 06958481412611 | K203390 | 000 |
| 06958481412628 | K203390 | 000 |
| 06958481412635 | K203390 | 000 |
| 06958481412642 | K203390 | 000 |
| 06958481412659 | K203390 | 000 |
| 06958481412512 | K203390 | 000 |