The following data is part of a premarket notification filed by Coaxia, Inc. with the FDA for Flocontrol , Model 1028.
| Device ID | K090970 |
| 510k Number | K090970 |
| Device Name: | FLOCONTROL , MODEL 1028 |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | COAXIA, INC. 10900 73RD AVE. N. Maple Grove, MN 55369 |
| Contact | Sharon D Kvistad |
| Correspondent | Sharon D Kvistad 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 | 2009-04-06 |
| Decision Date | 2009-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849111030014 | K090970 | 000 |