The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Transit Infusion Catheter (neurovascular Use).
| Device ID | K936282 |
| 510k Number | K936282 |
| Device Name: | TRANSIT INFUSION CATHETER (NEUROVASCULAR USE) |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Marlene Wright |
| Correspondent | Marlene Wright CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-30 |
| Decision Date | 1994-07-18 |