The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Hypertransit Infusion Catheter.
| Device ID | K043538 |
| 510k Number | K043538 |
| Device Name: | HYPERTRANSIT INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
| Contact | Maritza Celaya |
| Correspondent | Maritza Celaya 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-22 |
| Decision Date | 2005-04-18 |
| Summary: | summary |