Dual Function Pacing Wedge Pressure Balloon Catheter
by J-Lloyd Medical, Inc. 510(k)
Active
510(k) K950440
Overview
The Dual Function Pacing Wedge Pressure Balloon Catheter is a diagnostic intravascular catheter designed for hemodynamic assessment and temporary cardiac pacing. It combines a pacing electrode with a balloon-tipped wedge for measuring intracardiac pressures, enabling simultaneous pacing and pressure monitoring during cardiac procedures. This dual-function capability supports accurate diagnosis and intervention in patients with cardiac conditions requiring both pacing and pressure data.
This device is supplied as a single-use, sterile catheter intended for use in clinical settings such as cardiac catheterization labs. It is classified under product code DQO and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of September 15, 1995. The catheter is intended for intravascular use and must be handled according to sterile procedures. No additional regulatory markings or MRI safety classifications are specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK950440 | Date15 Sep 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Dual Function Pacing Wedge Pressure Balloon Catheter by J-Lloyd
- 510(k) Number
- FDA Product Code
- DQO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1200
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from J-Lloyd Medical, Inc.
Questions
What is the Dual-Function Pacing Wedge Pressure Balloon Catheter used for?
This catheter combines two key functions: temporary cardiac pacing and intracardiac pressure measurement. It is designed for use during cardiac procedures where clinicians need to both stimulate the heart rhythmically and monitor pressures within the heart chambers simultaneously. This dual capability helps improve diagnostic accuracy and guide interventions for patients with conditions requiring both pacing support and pressure data.
Is the Dual-Function Pacing Wedge Pressure Balloon Catheter single-use or reusable?
The catheter is supplied as a single-use device. This ensures sterility and reduces the risk of cross-contamination between patients, which is critical in clinical settings like cardiac catheterization labs where infection control is paramount.
How should the Dual-Function Pacing Wedge Pressure Balloon Catheter be stored?
Since it is a sterile, single-use device, storage must maintain its integrity until use. The packaging should be kept in a clean, dry environment, away from direct sunlight or extreme temperatures. Always follow the manufacturer’s instructions for storage to preserve sterility and functionality.
What product code and regulatory pathway does this catheter follow?
This device is classified under product code DQO and received FDA 510(k) clearance through the Traditional pathway. The clearance was granted by the Cardiovascular (CV) Advisory Committee on September 15, 1995, confirming its substantial equivalence to a predicate device.
Can this catheter be used in MRI environments?
The available data does not specify any MRI safety classifications for this catheter. If MRI compatibility is required, additional precautions or alternative devices should be considered to ensure patient safety during imaging.