The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Paragon Infusion.
| Device ID | K984146 |
| 510k Number | K984146 |
| Device Name: | PARAGON INFUSION |
| Classification | Set, Administration, Intravascular |
| Applicant | I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Contact | Robert J Bard |
| Correspondent | Robert J Bard I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-19 |
| Decision Date | 1999-02-09 |
| Summary: | summary |