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Arrow Brachial Central Venous Cath-Kit W 16ga Ec
Arrow Intl.
Summary: The Arrow Brachial Central Venous Cath-Kit is a medical device used for central venous access, primarily in critical care settings. It is utilized by healthcare professionals such as anesthesiologists and intensivists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K854137 ↗
Decision Date ?
December 3, 1985
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Arrow Brachial Central Venous Cath-Kit was cleared via the FDA 510k pathway on December 3, 1985. It is manufactured by Arrow Intl. and classified as a Class 2 device under the product code DQY.
What It Is
The Arrow Brachial Central Venous Cath-Kit is designed for central venous access through the brachial vein. It includes a 16-gauge catheter and is used to facilitate the administration of medications, fluids, and for monitoring central venous pressure. The device is particularly useful in situations where peripheral access is challenging or when long-term venous access is required.
FDA-Cleared Indications
- Central venous access through the brachial vein for administration of medications and fluids.
- Central venous access for central venous pressure monitoring.
Clinical Applications
- Establishing central venous access through the brachial vein.
- Administering intravenous medications through central venous access.
- Administering fluids when peripheral venous access is inadequate.
- Monitoring central venous pressure.
Reported off-label uses
- Use as a peripherally inserted central catheter-type access route for longer-term intravenous therapy may occur in clinical practice, but the specific indication should be verified against the product labeling.
- Use for administration of medications or solutions not specifically identified in the labeling may be considered off-label and requires clinician judgment.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The record identifies a 16-gauge catheter; exact catheter length, lumen configuration, introducer components, and kit contents should be confirmed in the current manufacturer documentation.
- Placement should use sterile technique and appropriate venous-access imaging, such as ultrasound guidance, when available.
- The catheter and any guidewire or accessory components must be compatible with the intended access technique, infusion requirements, and monitoring equipment.
- MRI safety is not established by the FDA record provided. Confirm the complete kit's MR Safe, MR Conditional, or MR Unsafe status with current labeling before an MRI examination.
- Potential complications include bleeding, infection, thrombosis, vessel injury, air embolism, malposition, and difficulty removing the catheter. Contraindications and precautions include local infection, thrombosed or inaccessible vessels, and patient-specific bleeding or coagulation risks.
Related Literature
The linked study titled 'Arrow brachial CVP air aspirating catheter placement with the IVECG technique' from 1988 explored the placement of the Arrow brachial catheter using the IVECG technique. Although the abstract is not available, the study likely focused on the efficacy and safety of this placement method. Limitations may include the lack of detailed outcomes and the study's age, which may not reflect current practices.
Frequently Asked Questions
What is the Arrow Brachial Central Venous Cath-Kit used for?
It is used for central venous access to administer medications, fluids, and monitor central venous pressure.
What specialties typically use this device?
Anesthesiologists, intensivists, and other critical care specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for central venous access for medication administration, fluid resuscitation, and monitoring central venous pressure.
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.