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510(k) Data Aggregation
K Number
K102048Device Name
ATRAUMATIC VASCULAR CLAMPS
Manufacturer
Date Cleared
2010-11-09
(111 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
**GEOMED MEDIZIN- TECHNIK GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GEOMED Vascular Clamps are intended for use for temporary occlusion of blood vessels during surgical procedures.
Device Description
The GEOMED Vascular Clamps are reusable devices and provided non sterile. They must be thoroughly cleaned and sterilized before use. GEOMED Vascular Clamps are made of Stainless Steel (following ASTM F 899-07). They are provided with ring handles and ratchet closures to adjust the amount of tension applied to the vessel for occlusion or partial occlusion. The GEOMED Vascular Clamps are available in a wide variety of shapes, sizes and lengths to accomodate to the individual needs of the surgeon. Based on the anatomy of the site, the surgical technique chosen, the size and type of blood vessel and occlusion desired, the surgeon decides which clamp to use. During surgery the handles and shanks need to be out of the field of vision of the operative site and therefore a wide variety of instrument figures and sizes is necessary. The Vascular Clamps occlude the arteries or veins with a tension that intends to produce minimal trauma to the vessels. They cover the vessel and stop the blood flow.
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