The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Guardia Access Embryo Transfer Catheter Sets And Sydney Ivf® Transfer Catheter.
| Device ID | K173686 |
| 510k Number | K173686 |
| Device Name: | Guardia Access Embryo Transfer Catheter Sets And Sydney IVF® Transfer Catheter |
| Classification | Catheter, Assisted Reproduction |
| Applicant | Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Contact | Naomi Funkhouser |
| Correspondent | Naomi Funkhouser Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-01 |
| Decision Date | 2018-04-11 |
| Summary: | summary |