📋 FDA Reference
Certodyn Raecg Universal Adapter
Summary: The Certodyn RAECG Universal Adapter is a medical device used in conjunction with venous stents. It is primarily utilized by interventional radiologists and vascular surgeons to facilitate procedures involving venous access.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K973371 ↗
Decision Date ?
November 24, 1997
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Certodyn RAECG Universal Adapter was cleared through the FDA 510(k) pathway on November 24, 1997. Manufactured by B. Braun Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Certodyn RAECG Universal Adapter is a specialized medical device designed to interface with venous stents. It serves as a connector or adapter that ensures compatibility and secure attachment between stents and other procedural equipment. This device is crucial in maintaining the integrity and functionality of venous stents during interventional procedures.
FDA-Cleared Indications
- For use as a percutaneous catheter device as described under FDA product code DQY.
- The available record does not provide additional FDA indication wording beyond the product classification and summary.
Clinical Applications
- Use in a percutaneous catheter-based vascular procedure when the device is selected according to its cleared labeling.
- Use by trained clinicians in hospital or procedural settings for catheter access or catheter-related device management.
Practical Considerations
- Confirm the current manufacturer instructions for use, intended connection, compatible catheter components, and available sizes before use.
- Do not assume compatibility with a venous stent or other implant solely from the product name; verify compatibility with the exact components used.
- Use sterile technique and inspect the adapter and packaging for damage or defects before the procedure.
- MRI safety status cannot be determined from the supplied FDA record; review the current labeling before MRI exposure.
- Contraindications, dwell time, and handling requirements should be taken from the current manufacturer labeling rather than inferred from the product code.
Procedures that use this device
Frequently Asked Questions
What is the Certodyn RAECG Universal Adapter used for?
It is used to facilitate the connection and secure attachment of venous stents during interventional procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use with venous stents in patients with obstructive venous diseases or compromised venous flow.
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.