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510(k) Data Aggregation
K Number
K980002Device Name
KOALA VASCULAR CLAMPS AND INSERTS
Manufacturer
Date Cleared
1998-06-18
(167 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
BOSS INSTRUMENTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Koala Vascular Clamps and Inserts are reusable, ring-handled stainless steel clamps for clamping delicate vessels during surgery. They are radiopaque, visualized under fluoroscopy. Designed for tip-first closure to prevent vessel roll-out. Applications include pulmonary, gastrointestinal procedures, peripheral clamping, thoracic procedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.
Device Description
The Boss Instrument Koala Vascular Clamps and inserts are reusable, ring-handled stainless steel instruments which have inserts which reduce trauma to the tissue being clamped.
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