The following data is part of a premarket notification filed by Spartan Micro with the FDA for Spartan Mc 0165.
| Device ID | K213451 |
| 510k Number | K213451 |
| Device Name: | Spartan MC 0165 |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Spartan Micro 3167 Skyway Ct Fremont, CA 94539 |
| Contact | Gary Avedovech |
| Correspondent | Gary Avedovech Spartan Micro 3167 Skyway Ct Fremont, CA 94539 |
| Product Code | QJP |
| Subsequent Product Code | DQY |
| Subsequent Product Code | KRA |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-26 |
| Decision Date | 2021-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B489MC0165ST0 | K213451 | 000 |