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P.D. Access Device: Is intended for use when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and introducer of this size or larger. These additional probe/needle models are being incorporated to broaden the product line in order to accommodate both user preference and patient anatomies for all age groups. P.D. Access Monitor: Is intended for use to audibly indicate the doppler response of blood flow within an artery or vein. It is intended for use only in conjunction with the P.D. Access Vascular Access Device.

The P.D. Access™ device is intended to be used in conjunction with the P.D. Access Dual Frequency Monitor for general vascular use. The P.D. Access device is intended for general vascular use for audibly indicating the Doppler response to blood flow within an artery or vein. The indications and intended use for the P.D. Access device is the same as the predicate devices manufactured by CardioVascular Dynamics (i.e., P.D. Access/SmartNeedle). Product technology, performance characteristics, specifications, components and materials of the P.D. Access device are similar to those of predicate devices.

FOCUS™-PV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the large vessels of the renal, femoral, popliteal, tibial, peroneal, iliac and profunda arteries and for treatment of obstructive lesions of native or synthetic arterovenous dialysis fistulae.

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The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmanNeedle® Monitor for general vascular use. The SmanNeedle® Monitor will also be marketed as the P.D. Access™ Monitor; and the Monitor graphics and labeling will be changed to reflect the name. Other than the name, the Monitors will be equivalent. There will be no change in safety and efficacy. The P.D. Access™ / SmartNeedle® Device is indicated and intended for general vascular use for monitoring the flow of blood within the vasculature. The indications and intended use for of the P.D. Access™ / SmartNeedle® Device are the same as predicate devices manufactured by CardioVascular Dynamics (the SmartNeedle").

The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmanNeedle® Monitor for general vascular use. The SmanNeedle® Monitor will also be marketed as the P.D. Access™ Monitor; and the Monitor graphics and labeling will be changed to reflect the name. Other than the name, the Monitors will be equivalent. There will be no change in safety and efficacy. Product specifications, components and materials of the P.D. Access™ / SmartNeedle® Device are similar to those of predicate devices.

The FOCUS™-PV Balloon Dilatation Catheter is a balloon dilatation catheter intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature.

The FOCUSTM PV Balloon Dilatation Catheter, styled after the Grüntzig technique, is a double lumen catheter with a balloon mounted at the distal tip. Dilatation Balloon catheters are used to exert radial force to dilate narrow vessel segments, based on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end of a catheter.