The following data is part of a premarket notification filed by Spartan Micro, Inc with the FDA for Spartan Ecoil System.
| Device ID | K180653 |
| 510k Number | K180653 |
| Device Name: | Spartan ECoil System |
| Classification | Device, Neurovascular Embolization |
| Applicant | Spartan Micro, Inc 3167 Skyway Court Freemont, CA 94539 |
| Contact | Mark Dias |
| Correspondent | Vikki M. O'connor Ambriel Associates, Inc. 411 Walnut St. Unit 9236 Green Cove Springs, FL 32043 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-13 |
| Decision Date | 2018-12-04 |