The following data is part of a premarket notification filed by Shape Memory Medical with the FDA for Impede-fx Embolization Plug.
| Device ID | K182390 |
| 510k Number | K182390 |
| Device Name: | IMPEDE-FX Embolization Plug |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Shape Memory Medical 807 Aldo Avenue, Suite 109 Santa Clara, CA 95054 |
| Contact | Meghan Reu |
| Correspondent | Meghan Reu Shape Memory Medical 807 Aldo Avenue, Suite 109 Santa Clara, CA 95054 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-04 |
| Decision Date | 2019-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B054IMPFX121 | K182390 | 000 |
| B054IMPFX081 | K182390 | 000 |
| B054IMPFX061 | K182390 | 000 |
| 10810041650051 | K182390 | 000 |
| 10810041650044 | K182390 | 000 |
| 10810041650037 | K182390 | 000 |