The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Cerepak Uniform, Uniform Xl, Uniform 3d, Heliform Soft, Heliform Xtrasoft, Heliform Xl, Heliform Xtrasoft Xl, Freeform, Freeform Mini, And Freeform Xtrasoft Detachable Coil Systems.
| Device ID | K220040 |
| 510k Number | K220040 |
| Device Name: | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, And Freeform XtraSoft Detachable Coil Systems |
| Classification | Device, Neurovascular Embolization |
| Applicant | Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Michael Liao |
| Correspondent | Michael Liao Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-05 |
| Decision Date | 2022-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704083016 | K220040 | 000 |