đź“‹ FDA Reference
datascope percor percutaneous introducer w peelabl
Datascope
Summary: The Datascope Percor Percutaneous Introducer is a medical device used to facilitate the insertion of catheters or other devices into the vascular system. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K902932 ↗
Decision Date
October 16, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Datascope Percor Percutaneous Introducer was cleared through the FDA 510(k) pathway on October 16, 1990. It is manufactured by Datascope and classified as a Class 2 device under product code DYB.
What It Is
The Datascope Percor Percutaneous Introducer is a peelable introducer sheath designed to provide a conduit for the insertion of catheters and other interventional devices into the vascular system. The peelable feature allows for easy removal after the procedure, minimizing trauma to the vessel. It is typically used in procedures requiring vascular access, such as angiography or embolization.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures like embolization, angioplasty, and catheter placement. It is particularly useful in patients requiring minimally invasive vascular interventions. The introducer is suitable for use in both hospital and outpatient settings, providing flexibility for various patient populations.
Indications for Use
The FDA indications suggest this device is intended for use in facilitating the introduction of catheters and other devices into the vascular system. It is suitable for patients undergoing procedures that require vascular access, such as those with vascular diseases or needing diagnostic imaging.
Practical Considerations
The introducer is available in various sizes to accommodate different catheter diameters and patient anatomies. It is important to select the appropriate size for the procedure to ensure compatibility and minimize vessel trauma. Clinicians should be familiar with the peelable technique to effectively use the device.
Frequently Asked Questions
What is the Datascope Percor Percutaneous Introducer used for?
It is used to facilitate the insertion of catheters or other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system, particularly in procedures requiring vascular access.
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.