Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K180248
VascuEase IC-1200-WH · Bio Compression Systems, Inc. · decided 2018-08-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VascuEase Replacement Sleeve, Left | GID-1000-L | Bio Compression Systems, Inc | JOW | 00812311023049 |
| VascuEase | IC-1200-WH | Bio Compression Systems, Inc | JOW | 00812311022011 |
| VascuEase Replacement Sleeve, Right | GID-1000-R | Bio Compression Systems, Inc | JOW | 00812311023063 |
| VascuEase Replacement Sleeves | GID-1000-PR | Bio Compression Systems, Inc | JOW | 00812311023056 |