Cleared Traditional

PhasTIPP

K212894 · LeMaitre Vascular, Inc. · Cardiovascular
Mar 2022
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K212894 is an FDA 510(k) clearance for the PhasTIPP, 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 review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K212894 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DWQ — Stripper, Vein, External
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4885