The following data is part of a premarket notification filed by Spartan Micro, Inc. with the FDA for Spartan Center Wire.
| Device ID | K220075 |
| 510k Number | K220075 |
| Device Name: | Spartan Center Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | Spartan Micro, Inc. 3184 Airway Ave, Suite C Costa Mesa, CA 92626 |
| Contact | Gary Avedovech |
| Correspondent | Gary Avedovech Spartan Micro, Inc. 3184 Airway Ave, Suite C Costa Mesa, CA 92626 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-10 |
| Decision Date | 2022-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B489CWP0060300 | K220075 | 000 |
| B489CWP0040150 | K220075 | 000 |