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510(k) Data Aggregation
K Number
K981061Device Name
INTRAVASCULAR RETRIEVAL DEVICE
Manufacturer
MED INSTITUTE, INC.
Date Cleared
1998-05-26
(64 days)
Product Code
GCC, DRE, DXE
Regulation Number
878.4200Why did this record match?
Product Code :
GCC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Byrd Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
The Byrd Stainless Steel Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
The Byrd WORK STATION™ is intended for use in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.
The Byrd Telescoping Stainless Steel Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
The NEEDLE'S EYE™ Snare is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides, and other foreign objects.
Device Description
The devices consist of sheaths and snares intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters, and foreign objects and/or in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.
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