The following data is part of a premarket notification filed by Spartan Micro, Inc. with the FDA for Spartan Sc 069.
| Device ID | K220716 |
| 510k Number | K220716 |
| Device Name: | Spartan SC 069 |
| Classification | Catheter, Percutaneous |
| Applicant | Spartan Micro, Inc. Costa Mesa, CA 92626 |
| Contact | Gary Avedovech |
| Correspondent | Gary Avedovech Spartan Micro 3184 Airway Ave, Suite C Costa Mesa, CA 92626 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-11 |
| Decision Date | 2022-05-05 |