K141822 is an FDA 510(k) clearance for the SENSEI X ROBOTIC CATHETER SYSTEM. This device is classified as a System, Catheter Control, Steerable (Class II - Special Controls, product code DXX).
Submitted by Hanson Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 5, 2014, 29 days after receiving the submission on July 7, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1290.
| 510(k) Number | K141822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2014 |
| Decision Date | August 05, 2014 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXX — System, Catheter Control, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1290 |