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510(k) Data Aggregation
K Number
K963092Device Name
MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER
Manufacturer
Date Cleared
1997-01-13
(158 days)
Product Code
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
ADAM SPENCER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ASC Maxi-Torque Plus Softip Angiographic Catheters are designed to deliver contrast medium to selected sites in the vascular system.
Device Description
The ASCMPSACs are classified as Class II in 21 CFR §870.1200. The ASCMPSACs are sterile, single use, disposable devices, that are delivered non-toxic and non-pyrogenic. The ASCMPSACs consist of five components: catheter hub with luer connector, catheter shaft, catheter stem, soft distal tip, and catheter shaft braid wire. The catheter shaft has three sub-components: extrusion base coat, reinforcement braid wire, and extrusion top coat. The braiding is intended to provide torque control and strength. All versions of the catheter are designed to accommodate a maximum guidewire diameter of 0.038 inches. The strain relief is imprinted with three descriptive dimensions: the French size of the catheter, minimum inside diameter, and the catheter working length.
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K Number
K964331Device Name
ASC HIGH PRESSURE BRAIDED TUBES
Manufacturer
Date Cleared
1997-01-13
(75 days)
Product Code
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
ADAM SPENCER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ASC High Pressure Braided Tubes are accessory devices to angiographic catheters intended to provide an extended luminal connection between an angiographic injector and an angiographic catheter for the purpose of delivering radiopaque contrast medium to selected sites in the vascular system.
Device Description
The HPBT are sterile, single use, disposable devices, that are delivered non-toxic and non-pyrogenic. The HPBT consists of braided polymeric tubing terminated at both ends with luer connectors. The luer connector may be one of three types: male rotating, or female. A typical HPBT is shown below. Cross-sectional views of the three luer connectors are shown on the next page. The tubing has three sub-components: extrusion base coat, reinforcement nylon braid, and extrusion top coat.
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