The following data is part of a premarket notification filed by Baxter Edwards with the FDA for Intramed Side Branch Occlusion (sbo) System (700095 And 700099).
| Device ID | K964021 |
| 510k Number | K964021 |
| Device Name: | INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) |
| Classification | Device, Neurovascular Embolization |
| Applicant | BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92714 -5686 |
| Contact | Paula A Torrianni |
| Correspondent | Paula A Torrianni BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92714 -5686 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1997-03-27 |
| Summary: | summary |