The following data is part of a premarket notification filed by Kaneka Medical America Llc with the FDA for I-ed Coil System.
| Device ID | K210638 |
| 510k Number | K210638 |
| Device Name: | I-ED COIL System |
| Classification | Device, Neurovascular Embolization |
| Applicant | Kaneka Medical America LLC 623 Fifth Avenue New York, NY 10022 |
| Contact | Audra Bogucki |
| Correspondent | Takeaki Miyata Kaneka Corporation 1-12-32, Akasaka Minato-ku, JP 107-6028 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-03 |
| Decision Date | 2021-03-26 |