The following data is part of a premarket notification filed by Gtimd Llc with the FDA for Aqueduct 200 Cervical Dilation Balloon Catheter.
| Device ID | K202433 |
| 510k Number | K202433 |
| Device Name: | Aqueduct 200 Cervical Dilation Balloon Catheter |
| Classification | Catheter, Balloon, Dilation Of Cervical Canal |
| Applicant | GTIMD LLC 6 Columbia Drive Amherst, NH 03031 |
| Contact | Eran Levit |
| Correspondent | Eran Levit GTIMD LLC 6 Columbia Drive Amherst, NH 03031 |
| Product Code | PON |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-25 |
| Decision Date | 2021-10-15 |