The following data is part of a premarket notification filed by Brosmed Medical Co., Ltd. with the FDA for Apollo Balloon Dilatation Catheter.
| Device ID | K153742 |
| 510k Number | K153742 |
| Device Name: | Apollo Balloon Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | BrosMed Medical Co., Ltd. 15th Bldg., SMEs Venture Park Songshan Lake Hi-Tech Development Zone Dongguan, CN |
| Contact | Tina Yin |
| Correspondent | Tina Yin BrosMed Medical Co., Ltd. 15th Bldg., SMEs Venture Park Songshan Lake Hi-Tech Development Zone Dongguan, CN |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-08-08 |
| Summary: | summary |