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Pharmaseal Over-The Needle Arterial Catheter Sta
American Pharmaseal Div. Ahsc
Summary: The Pharmaseal Over-the-Needle Arterial Catheter STA is a Class 2 medical device used for arterial access. It is commonly used by clinicians in critical care and surgical settings for monitoring arterial blood pressure and obtaining blood samples.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K853714 ↗
Decision Date ?
January 13, 1986
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Pharmaseal Over-the-Needle Arterial Catheter STA was cleared through the FDA 510k pathway on January 13, 1986. It is manufactured by American Pharmaseal Div. Ahsc and classified as a Class 2 device under product code DQY.
What It Is
The Pharmaseal Over-the-Needle Arterial Catheter STA is a medical device designed for arterial access. It consists of a catheter placed over a needle, allowing for easy insertion into an artery. This device is used to monitor arterial blood pressure continuously and to obtain arterial blood samples for analysis. Its design facilitates quick and reliable access to the arterial system, which is crucial in critical care settings.
FDA-Cleared Indications
- Percutaneous catheterization of an artery for arterial access.
- Continuous monitoring of arterial blood pressure.
- Collection of arterial blood samples for laboratory analysis.
Clinical Applications
- Establishing arterial access in an operating room or critical-care setting.
- Continuous invasive arterial blood pressure monitoring during major surgery or critical illness.
- Obtaining repeated arterial blood samples when frequent testing is clinically necessary.
- Connecting arterial access to a compatible pressure-monitoring system.
Practical Considerations
- The catheter is inserted over a needle using standard percutaneous arterial catheterization technique; the access site and catheter size depend on the patient and clinical purpose.
- It is intended for use by trained clinicians familiar with arterial access, sterile technique, pressure monitoring and management of vascular complications.
- Compatibility with pressure tubing, transducers and sampling systems should be confirmed before use.
- Potential complications include bleeding, hematoma, thrombosis, distal ischemia, infection, arterial injury and loss of catheter function.
- The FDA record provided does not establish MRI safety, specific catheter sizes, dwell time or a universal contraindication list. Consult the product labeling and institutional policy before MRI or prolonged placement.
Frequently Asked Questions
What is the Pharmaseal Over-the-Needle Arterial Catheter STA used for?
It is used for continuous arterial blood pressure monitoring and obtaining arterial blood samples.
What specialties typically use this device?
Anesthesiology, critical care, and surgery are the main specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for continuous arterial blood pressure monitoring and frequent arterial blood sampling in critical care and surgical settings.
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.