K121415 is an FDA 510(k) clearance for the MOLLRING MULTITASC. This device is classified as a Stripper, Artery, Intraluminal (Class II - Special Controls, product code DWX).
Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on September 5, 2012, 117 days after receiving the submission on May 11, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K121415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2012 |
| Decision Date | September 05, 2012 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWX — Stripper, Artery, Intraluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4875 |