510(k) K100984
- Device
- XYLOS VESSEL GUARD
- Applicant
- XYLOS CORPORATION
- 510(k) number
- K100984
- Product code
- OMR
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2010-07-07
- Date received
- 2010-04-08
- Regulation
- 870.3470
- Classification name
- Vessel Guard Or Cover
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOYCE ELKINS
- Address
- 838 Town Center Dr. Langhorne PA US 19047 19047
FDA Registration Numbers#
- 3008812560
- 2029275
Source Documents#
Other 510(k) Records For Product Code OMR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111048 | SYNTHES SCOUT TACK FIXATION | Synthes Spine | 2012-06-14 |
| K111137 | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | 2011-05-20 |
| K101805 | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | 2011-04-08 |
| K103558 | SYNTHES SCOUT VESSEL GUARD | Synthes Spine | 2011-02-18 |
| K101826 | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 | Mimedx Group, Inc. | 2010-07-28 |
| K100905 | HYDROFIX SURGICAL SHEET | Mimedx Group, Inc. | 2010-06-02 |
| K093551 | PARADIS VASO SHIELD | Spinemedica, LLC | 2009-12-24 |
| K090022 | PARADIS VASO SHIELD | Spinemedica, LLC | 2009-04-20 |
| K082782 | REPLICATION MEDICAL VESSEL GUARD | Replication Medical, Inc. | 2009-04-02 |
Legacy Summary#
summary
FDA Review#
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