The following data is part of a premarket notification filed by Brosmed Medical Co., Ltd. with the FDA for Polux , Minerva And Atropos Pta Balloon Dilatation Catheter.
| Device ID | K160256 |
| 510k Number | K160256 |
| Device Name: | Polux , Minerva And Atropos PTA Balloon Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Brosmed Medical Co., Ltd. 15th Bldg., SMEs Venture Park, Songshan Lake Hi-Tech Development Zone Dongguan, CN 523808 |
| Contact | Tina Yin |
| Correspondent | Stephen Lee Brosmed Medical Co., Ltd. 15th Bldg., SMEs Venture Park SongShan Lake Hi-Tech Development Zone Dongguan, CN 523808 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-07-29 |
| Summary: | summary |