Moerae Vein Preparation Kit

FDA 510(k) K131659 · Moerae Matrix, Inc.

Substantially Equivalent

510(k) numberK131659

Submission

Device name
Moerae Vein Preparation Kit
Applicant
Moerae Matrix, Inc.
San Carlos, CA, US
Received
June 6, 2013
Decision date
March 3, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GBX – Catheter, Irrigation
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Specialty
General, Plastic Surgery

Other 510(k)s with product code GBX

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K082725Graftguard Pressure Controlling SyringeGBX · Traditional Maquet Cardiovascular, LLC12/17/2008SE
K052286Deutsch Anti-Blockage Wound DrainGBX · Traditional The Catheter Exchange, Inc.10/21/2005SE
K043515GraftsaverGBX · Traditional Vescare, Inc.03/31/2005SE
K013417Misonix Irrigation System Moedl BC20PGBX · Traditional Misonix, Inc.01/10/2002SE
K000704DMC Saphenous Vein Distention System (SVDS)GBX · Traditional Dmc Medical, Ltd.05/19/2000SE
K974233Lysonix Irrigation SystemGBX · Traditional Lysonix, Inc.02/03/1998SE
K973703Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional Allegiance Healthcare Corp.12/04/1997SE
K972635Ultracell Suction SpongeGBX · Traditional Ultracell Medical Technologies, Inc.10/01/1997SE
K965146Flat Closed Wound Drain with TrocarGBX · Traditional Axiom Medical, Inc.03/10/1997SE
K961295Sapphire Line Flat Drain/Kit with Spi-Argent II W/Or W/Out TrocarGBX · Traditional Sil-Med Corp.06/26/1996SE

Questions and answers

When was Moerae Vein Preparation Kit cleared by the FDA?

Moerae Vein Preparation Kit (K131659) received a 510(k) decision of Substantially Equivalent on March 3, 2014, 270 days after the submission was received.

What is the product code of K131659?

The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.