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FDA 510(k)

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

K-Number: K022823 · 2004-07-01

ApplicantGeister Medizin Technik GmbH
Decision Date2004-07-01
Product CodeMGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 is the device name listed in this FDA 510(k) record. The listed applicant is Geister Medizin Technik GmbH. It received FDA 510(k) clearance on 2004-07-01 under 510(k) number K022823. The device is classified under product code MGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520?

VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 is a medical device that received FDA 510(k) clearance on 2004-07-01. The listed applicant is Geister Medizin Technik GmbH. The 510(k) number is K022823.

When did VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 receive FDA 510(k) clearance?

VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 received FDA 510(k) clearance on 2004-07-01, under 510(k) number K022823.

Who is the listed applicant for VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520?

The FDA 510(k) record lists Geister Medizin Technik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520?

The FDA product code for VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 is MGZ.

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Other records listing Geister Medizin Technik GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242759Geister K-Rex rongeursK180610Geister retractor for neuro - and spine surgeryK030788KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORSK982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATK933699GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS

Related Devices (Code: MGZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260188LimFlow VectorLimFlow, Inc.K250105Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc.K221902LimFlow VectorLimFlow, Inc.K190267EZE SIT ValvulotomeLemaitre VascularK132047LEMILLS VALVULOTOMELeMaitre Vascular, Inc.K132190EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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