The following data is part of a premarket notification filed by Flowmedica, Inc. with the FDA for Benephit Bifurcated Infusion Catheter And 5fr. Introducer Sheath.
| Device ID | K050205 |
| 510k Number | K050205 |
| Device Name: | BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-28 |
| Decision Date | 2005-03-04 |