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 |