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510(k) Data Aggregation
K Number
K960801Device Name
SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)
Manufacturer
Date Cleared
1996-03-29
(31 days)
Product Code
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN INSTRUMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Selector Angiographic Catheter is intended to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures. Selector Angiographic Catheters are intended for single-patient use only.
Device Description
The Selector Angiographic Catheter consists of a radiopaque shaft with an attached molded female luer lock hub. The shaft of the catheter includes a flexible section and an optional soft distal tip. The Selector Angiographic catheter may vary with respect to length, diameter, curve style, and the number of side holes present. Selector Angiographic Catheters can be introduced into the selected blood vessel by either cutdown or percutaneous entry techniques.
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K Number
K955554Device Name
HEMO-VALVE
Manufacturer
Date Cleared
1996-03-04
(90 days)
Product Code
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN INSTRUMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HEMO-Valve is recommended for use in angiographic procedures involving blood or other potentially infectious materials, so that the procedure can be performed in such a manner as to minimize blood loss and patient/user exposure to these substances. The HEMO-Valve is intended for use in intra-arterial and intravenous administration of fluids, including radiographic contrast media.
Device Description
The HEMO-Valve consists of an elastomeric valve located between male and female luer lock fittings. The valve may be opened by connecting a male luer lock (the luer fitting pushes the gland out of the way) or may be opened by introducing a guidewire in a forward or backloading manner.
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K Number
K960310Device Name
EPIC INTRODUCER SHEATH
Manufacturer
Date Cleared
1996-02-07
(16 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN INSTRUMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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