Cleared Traditional

VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520

K022823 · Geister Medizin Technik GmbH · Cardiovascular
Jul 2004
Decision
675d
Days
Class 2
Risk

About This 510(k) Submission

K022823 is an FDA 510(k) clearance for the VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520, a Valvulotome (Class II — Special Controls, product code MGZ), submitted by Geister Medizin Technik GmbH (Hot Springs, US). The FDA issued a Cleared decision on July 1, 2004, 675 days after receiving the submission on August 26, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K022823 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2002
Decision Date July 01, 2004
Days to Decision 675 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code MGZ — Valvulotome
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4885

Similar Devices — MGZ Valvulotome

All 25
Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
K250105 · Aveera Medical, Inc. · Jul 2025
LimFlow Vector
K221902 · LimFlow, Inc. · Dec 2022
EZE SIT Valvulotome
K190267 · Lemaitre Vascular · Oct 2019
Antegrade LeMills Valvulotome
K142660 · LeMaitre Vascular, Inc. · Oct 2014
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
K140042 · LeMaitre Vascular, Inc. · Apr 2014
LEMILLS VALVULOTOME
K132047 · LeMaitre Vascular, Inc. · Nov 2013

More from Geister Medizin Technik GmbH

View all
Geister K-Rex rongeurs
K242759 · HAE · Jun 2025
Geister retractor for neuro - and spine surgery
K180610 · GZT · Aug 2018
KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
K030788 · DWP · Jul 2003
ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT
K982365 · DXC · Apr 1999
GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS
K933699 · GEI · Jan 1994