The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Vascuease Ic-1200-wh.
| Device ID | K180248 |
| 510k Number | K180248 |
| Device Name: | VascuEase IC-1200-WH |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Bio Compression Systems, Inc. 120 W Commercial Ave Moonachie, NJ 07074 |
| Contact | Barbara Whitman |
| Correspondent | Jonathan Ross Bio Compression Systems, Inc. 120 W Commercial Ave Moonachie, NJ 07074 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-29 |
| Decision Date | 2018-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812311023063 | K180248 | 000 |
| 00812311023056 | K180248 | 000 |
| 00812311023049 | K180248 | 000 |
| 00812311022011 | K180248 | 000 |