The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Fenestrated Infusion Catheter.
| Device ID | K024190 |
| 510k Number | K024190 |
| Device Name: | FENESTRATED INFUSION CATHETER |
| Classification | Pump, Infusion |
| Applicant | PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-19 |
| Decision Date | 2003-03-17 |
| Summary: | summary |