The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Isoflux Ixl Flow Regulator.
| Device ID | K925733 |
| 510k Number | K925733 |
| Device Name: | ISOFLUX IXL FLOW REGULATOR |
| Classification | Set, Administration, Intravascular |
| Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-13 |
| Decision Date | 1994-05-09 |