The following data is part of a premarket notification filed by Xylos Corporation with the FDA for Xylos Vessel Guard.
| Device ID | K100984 |
| 510k Number | K100984 |
| Device Name: | XYLOS VESSEL GUARD |
| Classification | Vessel Guard Or Cover |
| Applicant | XYLOS CORPORATION 838 TOWN CENTER DR. Langhorne, PA 19047 |
| Contact | Joyce Elkins |
| Correspondent | Joyce Elkins XYLOS CORPORATION 838 TOWN CENTER DR. Langhorne, PA 19047 |
| Product Code | OMR |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-08 |
| Decision Date | 2010-07-07 |
| Summary: | summary |