The following data is part of a premarket notification filed by Bresagen, Inc. with the FDA for Bresagen Catheter, Model Cs-3000.
| Device ID | K021481 |
| 510k Number | K021481 |
| Device Name: | BRESAGEN CATHETER, MODEL CS-3000 |
| Classification | Catheter, Ventricular |
| Applicant | BRESAGEN, INC. 111 RIVER BEND RD. Athens, GA 30605 |
| Contact | John Kucharczyk |
| Correspondent | John Kucharczyk BRESAGEN, INC. 111 RIVER BEND RD. Athens, GA 30605 |
| Product Code | HCA |
| CFR Regulation Number | 882.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-08 |
| Decision Date | 2002-08-06 |