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510(k) Data Aggregation
K Number
K030260Device Name
GELBFISH FLEX VASCULAR DILATOR
Manufacturer
Date Cleared
2003-02-20
(27 days)
Product Code
Regulation Number
870.1310Why did this record match?
Applicant Name (Manufacturer) :
VASCUMETRIX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These devices are intended to be used over a guidewire to dilate or calibrate blood vessels.
Device Description
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K Number
K023507Device Name
MODIFICATION TO GELBFISH VASCULAR DILATORS
Manufacturer
Date Cleared
2002-11-08
(21 days)
Product Code
Regulation Number
870.1310Why did this record match?
Applicant Name (Manufacturer) :
VASCUMETRIX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VascuMetrix Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels.
Device Description
Not Found
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K Number
K012256Device Name
GELBISH VASCULAR DILATOR
Manufacturer
Date Cleared
2001-12-20
(155 days)
Product Code
Regulation Number
870.1310Why did this record match?
Applicant Name (Manufacturer) :
VASCUMETRIX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VascuMetrix Gelbfish™ Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels.
Device Description
The VascuMetrix Gelbfish™ Vascular Dilators consist of a small diameter stainless steel tube with a smooth stainless steel tip welded to one end. The lumen of the tube sicer tube with a slide over an 0.035" guidewire. The tips are available in ten sizes and can be used to dilate or calibrate the lumen of a blood vessel.
The dilator can be inserted into a blood vessel either through a surgical cutdown or I he unator can of inserted int for use only by physicians using sterile technique. It is shipped sterile and intended as a single use device.
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