Wedge Pressure Balloon Catheter

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

Full name

Wedge Pressure Balloon Catheter by J-Lloyd

510(k) Number

K920873 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Flow Directed Thermodilution Balloon Catheter

  Class II

  FDA 510(k) K920869 Active Cleared 13 Jan 1993

• Bipolar Balloon Pacing Catheter by J-Lloyd

  Class II

  FDA 510(k) K930069 Active Cleared 28 Jan 1994

• Wedge Pressure Balloon Catheter by J-Lloyd

  Class II

  FDA 510(k) K935403 Active Cleared 12 May 1994

• Angiographic Balloon Catheter by J-Lloyd

  Class II

  FDA 510(k) K935402 Active Cleared 26 Apr 1994

• Flow Direct Thermodilut Balloon Cath Heparin Coated

  Class II

  FDA 510(k) K940547 Active Cleared 11 Aug 1994

• Hexapolar Electrode Balloon Flotation Catheter

  Class II

  FDA 510(k) K971504 Active Cleared 20 Apr 1998

See all devices from J-Lloyd Medical, Inc. →

• What clinical scenarios is the Wedge Pressure Balloon Catheter primarily used for, and how does its dual-lumen design benefit the procedure?

  The Wedge Pressure Balloon Catheter is primarily used in cardiac catheterization labs to measure pressures within the cardiovascular system, specifically to assess wedge pressure—a critical indicator of left atrial and pulmonary capillary pressures. The dual-lumen design allows simultaneous pressure measurement *and* fluid administration during the procedure, which is essential for tasks like administering contrast agents or medications while maintaining occlusion via the balloon. This dual functionality streamlines workflow and reduces the need for additional catheters.

• Is this device intended for reuse, or is it strictly single-use? How does that affect its packaging and sterility?

  The Wedge Pressure Balloon Catheter is explicitly designed for single-use only, as stated in its description. This means it is supplied sterile and packaged for direct procedural use, eliminating the need for reprocessing or cleaning. The sterile packaging ensures safety and reliability for one-time clinical application, which is standard practice for intravascular diagnostic devices to prevent cross-contamination and maintain performance integrity.

• What materials is the catheter constructed from, and does its radiopacity affect its visibility during procedures?

  The catheter is constructed from extruded radiopaque polymeric tubing, meaning it contains materials that are visible under fluoroscopy. This radiopacity is crucial during procedures like cardiac catheterization, as it allows clinicians to visualize the catheter’s position within the cardiovascular system in real time, ensuring accurate placement and proper occlusion of blood flow via the balloon.

• How is the device classified under FDA regulations, and what does that classification imply for its oversight and safety standards?

  The Wedge Pressure Balloon Catheter is classified as Class II under FDA regulations, which means it is subject to special controls for diagnostic catheters. This classification implies that while it does not require the stringent pre-market approval process of Class III devices, it still undergoes rigorous review through the 510(k) pathway (traditional clearance, K920873) to ensure compliance with performance standards. The clearance was granted under the Cardiovascular (CV) advisory committee, reflecting its role in intravascular diagnostics.

• What sizes or models are available for the Wedge Pressure Balloon Catheter, and how might a clinician determine the appropriate size for a patient?

  The provided data does not specify exact sizes or models available for the Wedge Pressure Balloon Catheter. However, like most intravascular catheters, variations in length, diameter, and balloon size are typically offered to accommodate different patient anatomies and procedural needs. Clinicians would typically select the appropriate size based on patient-specific factors (e.g., body size, vascular access point) and the specific diagnostic requirements of the procedure, often consulting manufacturer documentation or procedural guidelines for recommendations.