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The Cordis AVIATOR PLUS PTA Balloon Dilatation catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac. femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

The Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter is a catheter with a distal balloon and utilizes a rapid exchange design and accepts a 0.014" guide wire. The catheter tip is tapered to facilitate crossing of tight lesions. The proximal hub is used as a balloon inflation port. Two radiopaque marker bands within the balloon indicate the dilating section of the balloon and aid in balloon placement.

The Cordis AMIIA PTA Balloon Dilatation catheter is intended for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.

The Cordis AMIIA PTA Balloon Dilatation Catheter is a catheter with a distal DURALYN™ inflatable balloon. The catheter utilizes a Rapid Exchange design, consisting of a single inflation lumen and a distal guide wire lumen. The guide wire lumen begins at the distal tip and terminates at the guide wire exit port. The guide wire exit port (hole) is approximately 25 cm from the distal tip. The maximum guide wire diameter that may be used is printed on the package label. The catheter tip is tapered to facilitate crossing of tight lesions. The proximal hub is used as a balloon inflation port. The balloon is inflated by injecting diluted contrast medium through this hub. Two radiopaque marker bands within the balloon indicate the dilating section of the balloon and aid in balloon placement. The nominal balloon diameter and length are printed on the identification band near the hub. The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. Consult the compliance table incorporated with the product, for diameters of the balloon at given pressures. The design of this catheter does not incorporate a lumen for distal dye injection. The balloon catheter with a usable shaft length of 142 cm has two proximal shaft markers (90 cm and 100 cm from the distal tip). Both indicate the relative position of the catheter tip to the distal end of the guiding catheter. An additional marker is located at the distal port exit notch and aids in locating the guide wire exit.

The InScope Precision Balloon Dilator - Wire Guided - with pre-loaded 0.035" guide wire - Is a sterile, single use, disposable dilator used in the alimentary tract (esophagus, pylorus and colon). In the sterile product packaging also a stopcock is provided to maintain pressure or vacuum by an inflation device. The balloon specific pressure / diameter relationship is represented on the labeling of each product. The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract (i.e. esophagus, pylorus and colon).

The subject InScope Precision Balloon Dilator - Wire Guided described in this submission is virtually identical to its predicate device(s), which already have received 510(k) concurrence. Compared to the previously cleared predicate device - InScope Precision Balloon Dilator - Fixed Wire, the subject InScope Precision Balloon Dilator - Wire Guided in this submission now resembles the Boston Scientific's CRE Wireguided Balloon Dilator, which already received FDA 510(k) concurrence.

The InScope™ Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.

The InScope Precision Balloon Dilator is a sterile, single use, disposable esophageal dilator. The InScope Precision Balloon Dilator contains three marking bands on the balloon to facilitate more precise centering the balloon within the stricture. The middle band is located at the center of the balloon at 5 cm distance from the shaft marker. The proximal and distal bands are set 2.5 cm from the centre band. The InScope Precision Balloon Dilator is provided with a stopcock to maintain pressure or vacuum. The InScope Precision Balloon Dilator is capable of 3 distinct and progressive larger diameters as a function of the applied inflation pressure. The specific pressure / diameter relationship is represented on the labeling of each product. The subject InScope Precision Balloon Dilator described in this submission is virtually identical to its predicate device (Boston Scientific's CRE Balloon dilatation catheter), which already has received FDA 510(k) concurrence.