MozecTM PTA 0.014"Rx

Dénomination commerciale

MozecTM PTA 0.014"Rx

18904224905297

B-18904224905297

Numéro de référence/catalogue

MR14050040B

GS1

Classe IIa

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Mozec™ PTA Balloon Dilatation Catheter (Rx 0.014”) is a "Rapid exchange" type catheter and consists of a Balloon (dilatation element) near the distal tip with double radiopaque marker bands which represent the approximate balloon working length at nominal pressure. The radiopaque markers ensure the accurate positioning of the balloon in the stenosis under fluoroscopy. The hypo tube shaft has a luer-lock connector (hub) for balloon inflation at its proximal end. The catheter has a soft tip which facilitates advancement of the catheter to and through the stenosis. The two coaxial lumens permit movement of guide wire and balloon inflation. Two markers are located on the proximal shaft at 90 and 100 cm from the distal tip to indicate catheter position. The proximal portion of the shaft has PTFE Coating while distal portion of the shaft has hydrophilic coating applied on it, in order to optimize proximal pushability with a smooth transition to distal shaft trackability. The guidewire access port is located at the soft tip of the catheter while the exit port (rapid exchange) is located 25cm away from the tip of the balloon. The compliance chart on the inner and outer label indicates change in balloon diameter for a given change in pressure. The compliance data is based on in vitro testing of balloons at 37°C temperature. -Guide wire compatibility: 0.014” - 0.014” Rx PTA Balloon Dilatation Catheter available with usable length of 150 cm. The Mozec™ PTA Balloon Dilatation Catheter is available in different balloon sizes. Nominal balloon diameters and lengths are printed on the hub.

URL des informations complémentaires

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Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• C010402020101PTA BALLOON DILATATION CATHETERS

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