K212894 is an FDA 510(k) clearance for the PhasTIPP. This device is classified as a Stripper, Vein, External (Class II - Special Controls, product code DWQ).
Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on March 31, 2022, 202 days after receiving the submission on September 10, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.
| 510(k) Number | K212894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2021 |
| Decision Date | March 31, 2022 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWQ — Stripper, Vein, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4885 |