The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Micrusframe, Deltafill, Deltaxsft, Galaxy G3, Galaxy G3 Xsft, And Galaxy G3 Mini Microcoil Delivery Systems.
| Device ID | K211344 |
| 510k Number | K211344 |
| Device Name: | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, And GALAXY G3 Mini Microcoil Delivery Systems |
| Classification | Device, Neurovascular Embolization |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Ariell Joiner |
| Correspondent | Ariell Joiner CERENOVUS 6303 Blue Lagoon Drive, Suite 315 Miami, FL 33126 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2021-05-28 |