The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for 1 Mass Transit Infusion Catheter, 1 Various.
| Device ID | K983003 |
| 510k Number | K983003 |
| Device Name: | 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS |
| Classification | Catheter, Continuous Flush |
| 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 | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-28 |
| Decision Date | 1998-09-17 |
| Summary: | summary |