The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Cordis Endovascular Temporary Occlusion Balloon Catheter.
| Device ID | K984214 |
| 510k Number | K984214 |
| Device Name: | CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER |
| Classification | Clamp, Vascular |
| Applicant | CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
| Contact | Alina Caraballo |
| Correspondent | Alina Caraballo CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-24 |
| Decision Date | 1999-08-10 |
| Summary: | summary |