The following data is part of a premarket notification filed by Flowmedica, Inc. with the FDA for Flowmedica Bifurcated Infusion System, Infusion Catheter And Introducer Sheath.
| Device ID | K033569 |
| 510k Number | K033569 |
| Device Name: | FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH |
| Classification | Catheter, Continuous Flush |
| Applicant | FLOWMEDICA, INC. 46563 FREMONT BLVD Fremont, CA 94538 |
| Contact | Jeff Elkins |
| Correspondent | Jeff Elkins FLOWMEDICA, INC. 46563 FREMONT BLVD Fremont, CA 94538 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-12 |
| Decision Date | 2004-01-13 |
| Summary: | summary |