A14BX030060090

RapidCross™ PTA Balloon Catheter

The RapidCross™ rapid exchange (RX) percutaneous transluminal angioplasty (PTA) catheter is used in treating distal lesions in the small vessels below the knee.

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Indications, Safety, and WarningsThis therapy is not for everyone. Please consult your physician. A prescription is required. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions.Reference statementIndications for Use: The RapidCross RX PTA Catheter is indicated to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, and infrapopliteal arteries.Contraindications: The RapidCross RX PTA Catheter is contraindicated for use in the coronary arteries or in the neurovasculature, or when unable to cross the target lesion with a guidewire.Potential Adverse Events: The potential adverse events (or complications) that may occur or require intervention with the use of this device include, but are not limited to, the following conditions: Allergic reaction; Aneurysm; Arrhythmia; Arteriovenous fistula; Bleeding requiring transfusion; Contrast medium reaction or renal failure; Death; Embolism; Endocarditis; Fever; Hematoma; Hemorrhage; Hypertension or hypotension; Infection; Inflammation; Intraluminal thrombus; Myocardial infarction; Pseudoaneurysm; Regional ischemia; Sepsis; Shock; Stenosis or restenosis; Stroke; Transient ischemic attack; Venous thromboembolism; Vessel injury (such as dissection, perforation, or rupture); Vessel spasm. If a serious incident related to the device occurs, immediately
report the incident to Medtronic and the applicable competent authority or regulatory body.Important: Please reference the Instructions for Use (IFU) or Electronic Instructions for Use (eIFU) at https://manuals.medtronic.com/manuals/ for a complete listing of indications, contraindications, warnings and precautions, adverse effects, and suggested procedure.Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.FTSOP113326-63c

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A14BX030060090

RapidCross™ PTA Balloon Catheter

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A14BX030060090 RapidCross™ PTA Balloon Catheter

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United States

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A14BX030060090

RapidCross™ PTA Balloon Catheter