SureCath ITP II Percutaneous Port Access Device
510(k) K875213
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK875213 | Date3 Mar 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LJT
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5965
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SureCath ITP II Percutaneous Port Access Device is a subcutaneous, implanted, intravascular infusion port and catheter. It is designed for long-term venous access, allowing repeated injections, infusions, or blood draws without repeated needle insertions into veins. The device consists of a reservoir implanted beneath the skin, connected to a catheter that extends into a central vein, facilitating reliable and secure vascular access for patients requiring chronic therapy or monitoring.
This device is supplied sterile and intended for single-use implantation by a healthcare professional in a clinical setting. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance (K875213) for use in general hospital environments. The product code LJT identifies this specific percutaneous port access device, which requires proper sterile handling, aseptic technique during implantation, and adherence to post-procedural care guidelines to ensure patient safety and device functionality.
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Questions
AI-generated answers, 1 Oct 2026
What is the SureCath ITP II Percutaneous Port Access Device used for?
The SureCath ITP II is designed for long-term venous access in patients requiring repeated injections, infusions, or blood draws. It eliminates the need for repeated needle insertions into veins by providing a subcutaneous reservoir connected to a catheter placed in a central vein. This ensures reliable, secure, and convenient vascular access for chronic therapy or monitoring.
How is the SureCath ITP II supplied and prepared for use?
The device is supplied sterile and intended for single-use implantation only. It must be implanted by a healthcare professional in a clinical setting using aseptic technique. Proper sterile handling and adherence to post-procedural care guidelines are critical to ensure patient safety and device functionality.
Is the SureCath ITP II reusable or intended for single-use?
The SureCath ITP II is explicitly designed for single-use implantation. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, patient safety, and device performance.
What regulatory approvals does the SureCath ITP II have?
The SureCath ITP II has received FDA 510(k) clearance (K875213) and is classified as a Class II medical device. It is intended for use in general hospital environments, adhering to FDA regulations for percutaneous port access devices.
How should the SureCath ITP II be stored before implantation?
The device must be stored in its original, sterile packaging until ready for use. It should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Ensure the packaging remains intact to maintain sterility before implantation.