The following data is part of a premarket notification filed by Abk Biomedical Inc with the FDA for Easi-vue Embolic Microspheres System.
| Device ID | K220567 |
| 510k Number | K220567 |
| Device Name: | Easi-Vue Embolic Microspheres System |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | ABK Biomedical Inc 155 Chain Lake Drive Unit 32 Halifax, CA B3S 1B3 |
| Contact | Brandi Woods |
| Correspondent | Brandi Woods ABK Biomedical Inc 155 Chain Lake Drive Unit 32 Halifax, CA B3S 1B3 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-28 |
| Decision Date | 2022-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850042341060 | K220567 | 000 |
| 10850042341053 | K220567 | 000 |
| 10850042341046 | K220567 | 000 |
| 00850042341032 | K220567 | 000 |
| 00850042341025 | K220567 | 000 |
| 00850042341018 | K220567 | 000 |