The following data is part of a premarket notification filed by Advanced Infusion, Inc. with the FDA for Sta Cath Attachable Infision Catheter, Model Sta20.
| Device ID | K061661 |
| 510k Number | K061661 |
| Device Name: | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | ADVANCED INFUSION, INC. 466 WEST ARROW HWY., UNIT H San Dimas, CA 91773 |
| Contact | James Christensen |
| Correspondent | James Christensen ADVANCED INFUSION, INC. 466 WEST ARROW HWY., UNIT H San Dimas, CA 91773 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-13 |
| Decision Date | 2006-10-18 |
| Summary: | summary |