The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Intrauterine Access Balloon Catheter, Selective Salpingography Catheter.
| Device ID | K181770 |
| 510k Number | K181770 |
| Device Name: | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Contact | Ian Herrman |
| Correspondent | Ian Herrman Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-03 |
| Decision Date | 2019-03-29 |