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510(k) Data Aggregation
K Number
K000825Device Name
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
Manufacturer
Date Cleared
2000-09-21
(191 days)
Product Code
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
MEDI-DYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K970401Device Name
MEDI-DYNE GUIDING CATHETER
Manufacturer
Date Cleared
1997-08-01
(179 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MEDI-DYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medi-Dyne, Inc. Coronary Guiding Catheter is a single-use, sterile, nonpyrogenic, disposable cardiovascular catheter with a large nontapered lumen that permits the injection of contrast medium, pressure monitoring, and the passage of interventional devices such as balloon dilation catheters, guide wires and stents.
The Medi-Dyne, Inc. Coronary Guiding Catheter is designed to be used for the intravascular introduction of medical instruments into the coronary and the peripheral vascular system.
Device Description
The Medi-Dyne, Inc. Coronary Guiding Catheter is a single-use, sterile, nonpyrogenic, disposable cardiovascular catheter with a large nontapered lumen that permits the injection of contrast medium, pressure monitoring, and the passage of interventional devices such as balloon dilation catheters, guide wires and stents.
The Medi-Dyne device is similar in construction and materials when compared to the predicate devices. For example, both the Medi-Dyne and predicate device is manufactured with a plastic luer, radiopacifier loaded plastic shaft (jacket), a radiopacifier loaded soft tip, a teflon lined lumen, and an encapsulated layer of stainless steel braid between the inner teflon/liner and the outer plastic jacket. In addition, the lumens are similar in size, the distal ends are nontapered and sideholes are available.
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