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(60 days)
The SABER™ .014 and SABERX™ .014 PTA Dilatation Catheters are intended to dilate stenoses in the peripheral vasculature, including femoral, popliteal and infra popliteal arteries. The device is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature.
The SABER™ .014 and SABERX™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter are single-use sterile devices, sterilized by ethylene oxide.
The SABER™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is an over-the-wire (OTW) coaxial lumen catheter with a semi-compliant balloon mounted on its distal end. It is compatible with 0.014" (0.3556 mm) guidewire. The catheter is available in working lengths of 90 cm and 150 cm with balloon diameters ranging from 1.25 mm to 5.0 mm, and balloon lengths ranging from 15 mm to 300 mm.
Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. For balloon lengths greater than or equal to 100 mm, the distal section will have two (2) adjacent marker bands and the proximal section will have one (1) marker band. For balloon lengths less than 100 mm, the distal and proximal section will each have one (1) marker band. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. SABER™ .014 balloons are coated with a dual-layer hydrophilic material designed to increase lubricity throughout the lifetime of the device.
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 chart on the tray label for typical diameters of the balloons at given pressures.
The balloon lumen is used to inflate and deflate the balloon. The nominal balloon size in printed on the hub. The guidewire lumen is used to track the catheter over a prepositioned guidewire.
The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.
The SABERX™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon. The catheter is available in working lengths of 90 cm, 150 cm and 200 cm with balloon diameters ranging from 1.25 mm to 6.0 mm, and balloon lengths ranging from 15 mm to 300 mm. The catheter utilizes a Rapid Exchange design, consisting of a single inflation lumen and a distal guidewire lumen. The guidewire lumen begins at the distal tip and terminates at the guidewire exit port. The proximal hub is used as a balloon inflation port.
Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. For balloon lengths greater than or equal to 100 mm, the distal section will have two (2) adjacent marker bands and the proximal section will have one (1) marker band. For balloon lengths less than 100 mm, the distal and proximal section will each have one (1) marker band. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. SABERX™ .014 balloons are coated with a dual-layer hydrophilic material designed to increase lubricity throughout the lifetime of the device.
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 chart on the tray label for typical diameters of the balloons at given pressures.
The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.
The associated accessories for SABERX™ .014 PTA Dilatation Catheter include:
- Flushing Needle
The SABER™ .014 and SABERX™ .014 PTA Dilatation Catheter are for use in a catherization lab, hospital or other suitable healthcare facility by appropriately trained medical professionals only.
The Cordis US Corp's SABER™ .014 and SABERX™ .014 PTA Dilatation Catheters, intended to dilate stenoses in peripheral vasculature and for post-dilation of stents, demonstrated substantial equivalence to predicate devices through various performance tests.
Here's an overview of the acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | MEM Elution, Hemolysis Assay, Complement Activation, In Vitro Mouse Lymphoma, Bacterial Mutagenicity, Guinea Pig Maximization Sensitization, Acute Systemic Injection, Intracutaneous Irritation, Materials Mediated Rabbit Pyrogen, Thromboresistance Evaluation | All tests successfully completed, indicating the devices are biocompatible for their intended use (limited contact duration ≤ 24 hours with circulating blood), in accordance with ISO 10993-1 and ISO 10993-1:2009/Cor 1:2010. |
| Sterilization | Ethylene Oxide Sterilization Cycle Validation | Sterilization cycle validated per ISO 11135:2014 to provide a Sterility Assurance Level (SAL) of 10^-6. Ethylene oxide and ethylene chlorohydrin residuals meet requirements for limited exposure devices ( |
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