đź“‹ FDA Reference

Arterial Pressure Monitoring Set/Tray

Spectrum Vascular

Compare similar devices

Summary: An arterial pressure monitoring set or tray is a sterile collection of components used to connect an arterial catheter to pressure-monitoring equipment. It is used to measure blood pressure continuously or obtain arterial pressure readings during diagnostic or interventional procedures.

FDA Clearance Information

Pathway ? 510(k)
Number ? K261455 ↗
Decision Date ? June 26, 2026
Product Code ? DQO Catheter, Intravascular, Diagnostic
Device Class ? Class 2
Evidence ? 0 studies

FDA-Cleared Indications

  • For connection of an intravascular arterial catheter to a pressure-monitoring system.
  • For monitoring arterial blood pressure during diagnostic or therapeutic vascular procedures.
  • For use with compatible pressure transducers, monitoring cables, and arterial access components according to the device labeling.

Clinical Applications

  • Continuous arterial pressure monitoring during catheter-based vascular procedures.
  • Measurement of pressure in an accessed artery during diagnostic angiography.
  • Monitoring blood pressure during embolization and other endovascular interventions.
  • Connection of an arterial catheter to a compatible patient-monitoring system in a hospital or procedure-room setting.

Practical Considerations

  • The set must be compatible with the arterial catheter, pressure transducer, monitoring cable, flush solution, and other components used by the facility.
  • Available configurations may differ in tubing length, connectors, stopcocks, flush devices, and included accessories; users should verify the package contents and specifications.
  • Use sterile technique and remove air from the pressure-monitoring tubing before connection, following the facility protocol and product instructions.
  • The set is intended for single-patient use unless the labeling specifically states otherwise; do not reuse or reprocess disposable components.
  • MRI compatibility depends on the complete setup, including the catheter, tubing, transducer, cables, and monitoring equipment. The device should not be taken into the MRI environment unless its labeling confirms that configuration is MR Safe or MR Conditional.

Procedures that use this device

Frequently Asked Questions

What is an arterial pressure monitoring set used for?

It connects an arterial catheter to a pressure transducer and monitor so clinicians can measure arterial pressure during vascular procedures or other monitored care.

Is an arterial pressure monitoring set MRI safe?

MRI safety depends on the specific set and the complete monitoring system. Check the manufacturer’s labeling before bringing any component into an MRI area.

What sizes are available for an arterial pressure monitoring set?

Configurations vary by manufacturer and may include different tubing lengths, connectors, stopcocks, and pressure-monitoring accessories. The exact sizes and components are listed in the product specifications and labeling.

How long does an arterial pressure monitoring set last?

These sets are generally sterile, single-use devices intended for one patient and one procedure or episode of care. They should be discarded according to the product labeling and facility policy.

How much does an arterial pressure monitoring set cost?

Cost varies by configuration, included components, hospital purchasing contract, and location. The manufacturer or medical-supply distributor can provide current pricing.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

📬 The IR Device Brief

One email a month: new FDA clearances, recalls and device pages in vascular & interventional radiology.

We'll email you a link to confirm. Unsubscribe any time.

Suggest edits

For manufacturers and their teams. Each field shows what the page says now: add, remove or rewrite anything, and leave the rest as is. LA Vascular reviews every change before it goes live.

About you