The following data is part of a premarket notification filed by Brosmed Medical with the FDA for Apollo Balloon Dilatation Catheter.
| Device ID | K133852 |
| 510k Number | K133852 |
| Device Name: | APOLLO BALLOON DILATATION CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | BROSMED MEDICAL 15TH-BUILDING,SMES VENTURE PARK,SONGSHAN LAKE HI-TECH DEVELOPMENT ZONE Dongguan, CN 523808 |
| Contact | Stephen Lee |
| Correspondent | Stephen Lee BROSMED MEDICAL 15TH-BUILDING,SMES VENTURE PARK,SONGSHAN LAKE HI-TECH DEVELOPMENT ZONE Dongguan, CN 523808 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-19 |
| Decision Date | 2014-09-19 |
| Summary: | summary |