The following data is part of a premarket notification filed by Omnisonics Medical Technologies with the FDA for Modified Omniwave Endovascular System.
| Device ID | K083335 |
| 510k Number | K083335 |
| Device Name: | MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM |
| Classification | Catheter, Continuous Flush |
| Applicant | OMNISONICS MEDICAL TECHNOLOGIES 66 CONCORD STREET, SUITE A Wilmington, MA 01887 |
| Contact | Anne M Kulis |
| Correspondent | Anne M Kulis OMNISONICS MEDICAL TECHNOLOGIES 66 CONCORD STREET, SUITE A Wilmington, MA 01887 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-12 |
| Decision Date | 2008-12-15 |
| Summary: | summary |