PTA Balloon Dilatation Catheter

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Cathscanner(R) PTA Balloon Dilatation Catheter

510(k) Number

K902454 ↗

FDA Product Code

LIT

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600

  Class II

  FDA 510(k) K911384 Active Cleared 25 Jun 1991

• Visions 8.2F Pv Ultrasonic Imaging Catheter (Model 88900)

  Class II

  FDA 510(k) K982329 Active Cleared 14 Jan 1999

• Endosonics Trak Back Device

  Class II

  FDA 510(k) K990271 Active Cleared 30 Aug 1999

• Cathscanner II Intravascular Ultrasonic Imaging Sy

  Class II

  FDA 510(k) K926252 Active Cleared 25 Oct 1993

• Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter, Model 85700

  Class II

  FDA 510(k) K000820 Active Cleared 5 Jun 2000

• Precept-Pt(Tm) Microsensor Pressure Monitor Cath.

  Class II

  FDA 510(k) K890492 Active Cleared 2 Mar 1989

See all devices from Endosonics Corp. →

• What is the primary use of the CATHSCANNER® PTA Balloon Dilatation Catheter in clinical practice?

  The CATHSCANNER® PTA Balloon Dilatation Catheter is specifically designed for peripheral angioplasty, meaning it is used to mechanically widen narrowed or blocked blood vessels in peripheral arteries. This is achieved through controlled inflation of the balloon within the catheter, helping restore blood flow in obstructed arterial pathways.

• Is the CATHSCANNER® PTA Balloon Dilatation Catheter intended for reuse, or is it single-use only?

  The device is explicitly labeled as single-use only, meaning it is not meant to be reused after a single procedure. This classification aligns with standard medical device safety protocols to prevent contamination and ensure patient safety.

• What guidewire compatibility does the CATHSCANNER® PTA Balloon Dilatation Catheter support, and how does this affect its use?

  The catheter is compatible with both 0.018-inch and 0.035-inch guidewires, and it is available in Rapid Exchange (RX) and Over-the-Wire (OTW) configurations. This flexibility allows clinicians to choose the appropriate guidewire based on the procedural requirements, ensuring compatibility with existing interventional cardiology workflows.

• How is the CATHSCANNER® PTA Balloon Dilatation Catheter supplied, and does it come pre-sterilized?

  The device is supplied as non-sterile, meaning it requires sterilization by the healthcare facility prior to use. This is a standard practice for certain medical devices to allow hospitals to use their preferred sterilization methods, ensuring optimal cleanliness and safety for each procedure.

• What regulatory pathway was followed for the FDA clearance of the CATHSCANNER® PTA Balloon Dilatation Catheter, and what does this imply for its use?

  The device received FDA 510(k) clearance (K902454) under the Traditional 510(k) Review pathway, with a classification of Class II. This implies that the device was determined to be substantially equivalent to a legally marketed predicate device and is regulated under stricter controls than Class I but not as stringent as Class III. Clinically, this means it is considered safe and effective for its intended use in peripheral arterial dilation under interventional cardiology protocols.