The following data is part of a premarket notification filed by Coaxia Inc with the FDA for Coaxia Flocontrol Catheter.
| Device ID | K023914 |
| 510k Number | K023914 |
| Device Name: | COAXIA FLOCONTROL CATHETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | COAXIA INC 10900 73RD AVE. N. Maple Grove, MN 55369 |
| Contact | Gregory W Sachs |
| Correspondent | Gregory W Sachs COAXIA INC 10900 73RD AVE. N. Maple Grove, MN 55369 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-25 |
| Decision Date | 2003-02-21 |
| Summary: | summary |