The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Vascular Occlusion System.
| Device ID | K983483 |
| 510k Number | K983483 |
| Device Name: | VASCULAR OCCLUSION SYSTEM |
| Classification | Device, Neurovascular Embolization |
| Applicant | CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
| Contact | Martine D Schneider |
| Correspondent | Martine D Schneider CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-05 |
| Decision Date | 1999-03-24 |
| Summary: | summary |