Lifeport Vascular Access Port
510(k) K895689
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895689 | Date27 Dec 1989 | 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- Withdrawn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, 21 Sep 2026
The Lifeport Vascular Access Port is an implanted, subcutaneous, intravascular port and catheter device designed for vascular access. It provides a subcutaneous access point for medical procedures requiring repeated vascular entry.
This device is supplied as a single-use or reusable product depending on the specific model and is intended for use in a hospital setting. The Lifeport Vascular Access Port is MRI safe and available in various sizes as specified by the manufacturer. It has received FDA 510(k) clearance with the product code LJT and is classified as a Class II medical device.
Other devices from Strato Medical Corp.
Questions
AI-generated answers, 21 Sep 2026
What is the Lifeport Vascular Access Port used for?
The Lifeport Vascular Access Port is an implanted, subcutaneous, intravascular port and catheter device designed for vascular access. It provides a subcutaneous access point for medical procedures requiring repeated vascular entry in a hospital setting.
Is the Lifeport Vascular Access Port single-use or reusable?
The Lifeport Vascular Access Port is supplied as either a single-use or reusable product depending on the specific model selected by the healthcare provider for their clinical needs.
What sizes are available for the Lifeport Vascular Access Port?
The Lifeport Vascular Access Port is available in various sizes as specified by the manufacturer, allowing clinicians to select the appropriate model for their patients' specific anatomical and clinical requirements.
What is the regulatory status of the Lifeport Vascular Access Port?
The Lifeport Vascular Access Port has received FDA 510(k) clearance with the product code LJT and is classified as a Class II medical device, indicating it meets specific safety and effectiveness requirements.