The following data is part of a premarket notification filed by Circinus Medical Technology, Llc with the FDA for Bolt Navigation System.
| Device ID | K213768 |
| 510k Number | K213768 |
| Device Name: | Bolt Navigation System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Circinus Medical Technology, LLC 4450 Arapahoe Avenue, Suite 1000 Boulder, CO 80303 |
| Contact | Patrick West |
| Correspondent | Alex Cadotte Mcra, Llc 803 7th St., NW , 3rd Floor Washington, DC 20001 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-01 |
| Decision Date | 2022-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B981BN00201101 | K213768 | 000 |
| B981BN0010101 | K213768 | 000 |