AMIGO REMOTE CATHETER SYSTEM
FDA 510(k) clearance DEN140009 · decided 2014-12-18
Clearance details
- K-number
- DEN140009
- Device name
- AMIGO REMOTE CATHETER SYSTEM
- Applicant
- Catheter Robotics, Inc.
- Decision
- Unknown
- Date received
- 2014-02-18
- Decision date
- 2014-12-18
- Days to decision
- 303 days
- Clearance type
- Direct
- Product code
- PJB
- Device class
- 2
- Regulation number
- 870.5700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mt. Olive, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (K193147) | Stereotaxis, Inc. | 2020-03-05 |
| Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (K192775) | Stereotaxis, Inc. | 2019-10-30 |
| Steerable catheter control system (K183027) | Stereotaxis, Inc. | 2019-09-06 |
Recalls involving this device
No recalls on record reference this clearance.