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510(k) Data Aggregation
K Number
K051042Device Name
METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000
Manufacturer
ANGIOMETRX INC.
Date Cleared
2005-08-05
(102 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ANGIOMETRX INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Metricath Gemini-P System is indicated for use in the renal, iliac and femoral arteries for:
- Balloon dilatation of the stenotic portion of an arterial lesion
- Post-delivery expansion of balloon expandable stents
- Measurement of arterial lumen cross sectional area and diameter proximal to a lesion, or within a stented section of artery.
Device Description
Not Found
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K Number
K042685Device Name
METRICATH SYSTEM
Manufacturer
ANGIOMETRX INC.
Date Cleared
2004-11-18
(50 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
ANGIOMETRX INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary, renal, iliac and femoral arteries. The Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous, transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of artery.
Device Description
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K Number
K024000Device Name
METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER
Manufacturer
ANGIOMETRX INC.
Date Cleared
2003-06-26
(204 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
ANGIOMETRX INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Metricath™ System is intended for measuring intravascular diameter and cross-sectional area, in the coronary arteries only.
The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary vasculature. Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of an artery.
Device Description
The Metricath™ System consists of two parts, the Metricath™ 1000 computer console, and the sterile, disposable Metricath™ Balloon Catheter. The Metricath™ System measures both artery lumen diameter and cross sectional area using a low-pressure balloon catheter inserted into the artery using standard interventional procedures and techniques. The Metricath™ System is indicated for use in patients who are candidates for percutaneous transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of an artery.
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