The following data is part of a premarket notification filed by Endoshape, Inc. with the FDA for Medusa Vascular Plug,.
| Device ID | K140796 |
| 510k Number | K140796 |
| Device Name: | MEDUSA VASCULAR PLUG, |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | ENDOSHAPE, INC. 2450 Central Ave Ste I Boulder, CO 80301 |
| Contact | Michael Parmenter |
| Correspondent | Michael Parmenter ENDOSHAPE, INC. 2450 Central Ave Ste I Boulder, CO 80301 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-31 |
| Decision Date | 2014-12-02 |
| Summary: | summary |