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Found 4 results
510(k) Data Aggregation
K Number
K180610Device Name
Geister retractor for neuro - and spine surgery
Manufacturer
Geister Medizintechnik GmbH
Date Cleared
2018-08-29
(174 days)
Product Code
GZT
Regulation Number
882.4800Why did this record match?
Applicant Name (Manufacturer) :
Geister Medizintechnik GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device intended for use as a specialized manual surgical instrument. It is reusable and intended to provide access to the thoracic and lumbar spinal column during minimally invasive and endoscopic surgical provides a selflocking type surgical retraction system with inflatable tissue protectors.
Device Description
GEISTER Medizintechnik GmbH Self-retaining Retractors are reusable manual instruments made from stainless steel, PEEK or titanium. They are sold unsterile and can be re-processed according the instructions for use.
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K Number
K022823Device Name
VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
Manufacturer
GEISTER MEDIZINTECHNIK GMBH
Date Cleared
2004-07-01
(675 days)
Product Code
MGZ
Regulation Number
870.4885Why did this record match?
Applicant Name (Manufacturer) :
GEISTER MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Geister Valvulotomeare designed to incise the valve cusps of the graft in coronary artery bypass graft (CABG) procedures.
Device Description
Not Found
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K Number
K030788Device Name
KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
Manufacturer
GEISTER MEDIZINTECHNIK GMBH
Date Cleared
2003-07-12
(122 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
Applicant Name (Manufacturer) :
GEISTER MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
Device Description
GEISTER vessel dilators
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K Number
K982365Device Name
ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT
Manufacturer
GEISTER MEDIZINTECHNIK GMBH
Date Cleared
1999-04-08
(275 days)
Product Code
DXC, SCU
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
GEISTER MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To temporarily occlude an artery or vein with correct tension to produce minimal trauma to vessels. The different sizes and models are designed according to the type and size of the blood vessels, anatomical sites, and surgical techniques. Bulldog clamps are self-closing and are used for small vessels. The closing pressure of the GLOVER clamps can be adjusted using a nut and spring.
Applying forceps are used to apply bulldog clamps in deep surgical wounds.
To secure vascular occlusion of small vessels during surgery and to secure vascular occlusion during pediatric surgery.
Device Description
Not Found
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