K142116 is an FDA 510(k) clearance for the LLD EZ. This device is classified as a Stylet, Catheter (Class II - Special Controls, product code DRB).
Submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on August 12, 2014, 8 days after receiving the submission on August 4, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1380.
| 510(k) Number | K142116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2014 |
| Decision Date | August 12, 2014 |
| Days to Decision | 8 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRB - Stylet, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1380 |