📊 Evidence-Based Reference
Arrow-Johans Ecg Adaptor
Arrow Intl.
Summary: The Arrow-Johans ECG Adaptor by Arrow Intl. is a device used in conjunction with venous stents for monitoring cardiac activity. It is FDA 510k cleared and linked to two clinical studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K843263 ↗
Decision Date ?
September 20, 1984
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Arrow-Johans ECG Adaptor was cleared through the FDA 510k pathway on September 20, 1984, by Arrow Intl. It is classified as a Class 2 device under product code DQY.
What It Is
The Arrow-Johans ECG Adaptor is designed to facilitate the monitoring of cardiac electrical activity in patients with venous stents. It serves as an interface between the patient and ECG monitoring systems, ensuring accurate cardiac data collection.
FDA-Cleared Indications
- Percutaneous use as a catheter accessory under the FDA product classification DQY.
- Use with compatible catheter systems according to the device labeling and the cleared 510(k) submission.
Clinical Applications
- Use during percutaneous catheter-based procedures when an ECG adaptor is specified by the compatible catheter system.
- Use in vascular access or endovascular procedures requiring the labeled Arrow-Johans adaptor and compatible monitoring equipment.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov, focusing on related cardiac monitoring techniques. However, specific details regarding sample sizes and study outcomes are not provided.
Reported Outcomes
Published studies report limited specific outcomes related to the Arrow-Johans ECG Adaptor. The studies primarily explore methodologies for cardiac monitoring, without direct efficacy results for this device.
Safety Profile
Reported complications include no specific adverse events directly linked to the Arrow-Johans ECG Adaptor in the provided studies. Safety data is not explicitly detailed in the available evidence.
Evidence Limitations
The evidence for the Arrow-Johans ECG Adaptor is limited, with a lack of detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles.
Practical Considerations
- Confirm compatibility with the catheter, guidewire, ECG monitor, connectors and other equipment before use.
- The available record does not list device dimensions, catheter sizes, materials or connection specifications; consult the original labeling or manufacturer instructions.
- Do not assume MRI safety. MRI compatibility should be verified from the original device labeling and the complete implanted or connected system.
- Inspect packaging and the adaptor before use, and follow sterile technique and the manufacturer's instructions.
- Contraindications, warnings, duration of use and handling requirements should be taken from the current product labeling; they are not fully available in the supplied FDA snapshot.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Arrow-Johans ECG Adaptor?
The device is indicated for use in cardiac monitoring, particularly in patients with venous stents, as per FDA documentation.
What outcomes have been reported in clinical studies?
Specific outcomes related to the Arrow-Johans ECG Adaptor are not detailed in the provided studies.
What complications have been reported?
Safety data from the evidence does not specify complications directly associated with the device.
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.