The following data is part of a premarket notification filed by Endobionics, Inc. with the FDA for Endobionics Microsyringe (usyringe) Infusion Catheter.
| Device ID | K040139 |
| 510k Number | K040139 |
| Device Name: | ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | ENDOBIONICS, INC. 3077 TEAGARDEN STREET San Leandro, CA 94577 -5720 |
| Contact | Kirk P Seward |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. P.O. BOX 5185 6802 ED ARNHEM Arnhem, NL |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-01-22 |
| Decision Date | 2004-02-18 |
| Summary: | summary |