📋 FDA Reference
Datascope Percor Percutaneous Introducer W Peelabl
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitates the percutaneous introduction of catheters and other devices into the vascular system.
- Provides temporary vascular access during diagnostic or interventional procedures that require catheter or device placement.
Clinical Applications
- Percutaneous vascular access for catheter-based diagnostic procedures.
- Introduction of catheters used for angiography.
- Introduction of devices used during vascular embolization procedures.
- Access for catheter-based vascular interventions when the introducer is compatible with the selected catheter or device.
Practical Considerations
- Select the sheath size and length to match the catheter or device, the access vessel, and the patient's anatomy.
- The sheath is intended for single-use vascular access; inspect the packaging and device before use and follow the current manufacturer instructions.
- Clinicians must use the peelable mechanism correctly to remove the introducer while maintaining control of the catheter or other indwelling device.
- Potential vascular-access complications include bleeding, hematoma, infection, thrombosis, vessel injury, embolization, and arterial or venous occlusion.
- MRI safety cannot be determined from the FDA record alone. Check the current product labeling for MR Safe, MR Conditional, or MR Unsafe status before MRI exposure.
Procedures that use this 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.