K152633 is an FDA 510(k) clearance for the Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on October 15, 2015, 30 days after receiving the submission on September 15, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K152633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2015 |
| Decision Date | October 15, 2015 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LDF — Electrode, Pacemaker, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3680 |