K140138 is an FDA 510(k) clearance for the HEARTNAVIGATOR RELEASE 2.0. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Philips Medical Systems Nederland B.V. (Lutz, US). The FDA issued a Cleared decision on June 10, 2014, 139 days after receiving the submission on January 22, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K140138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2014 |
| Decision Date | June 10, 2014 |
| Days to Decision | 139 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB — Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |