The following data is part of a premarket notification filed by Advanced Infusion, Inc. with the FDA for Polyurethane Infusion Catheter, Alpha Cath, Model Pac20, And Polyurethane Infusion Catheter, Multi Drip, Model Pmd20-6.
| Device ID | K061356 |
| 510k Number | K061356 |
| Device Name: | POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 |
| Classification | Sterilant, Medical Devices |
| Applicant | ADVANCED INFUSION, INC. 920 EAST UNIVERSITY DR. SUITE D202 Tempe, AZ 85281 |
| Contact | James Christensen |
| Correspondent | James Christensen ADVANCED INFUSION, INC. 920 EAST UNIVERSITY DR. SUITE D202 Tempe, AZ 85281 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-15 |
| Decision Date | 2006-07-03 |
| Summary: | summary |