Cleared Traditional

K131659 - MOERAE VEIN PREPARATION KIT
(FDA 510(k) Clearance)

K131659 · Moerae Matrix, Inc. · General & Plastic Surgery device

Mar 2014

Decision

270d

Days

Class 1

Risk

K131659 is an FDA 510(k) clearance for the MOERAE VEIN PREPARATION KIT. This device is classified as a Catheter, Irrigation (Class I - General Controls, product code GBX).

Submitted by Moerae Matrix, Inc. (San Carlos, US). The FDA issued a Cleared decision on March 3, 2014, 270 days after receiving the submission on June 6, 2013.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number	K131659 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 06, 2013
Decision Date	March 03, 2014
Days to Decision	270 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF