Infuse-a-Port Explant Kit
by Intermedics/Infusaid, Inc. 510(k)
Active
510(k) K863296
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863296 | Date11 Sep 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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, 27 Sep 2026
The Infuse-a-Port Explant Kit is a device used for the removal of implanted subcutaneous intravascular ports and catheters. It is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular device under FDA regulation number 880.5965.
The kit received traditional 510(k) clearance (K863296) on September 11, 1986, and is substantially equivalent to a legally marketed device. It is supplied by Intermedics/Infusaid, Inc. and is intended for use in general hospital settings.
Other devices from Intermedics/Infusaid, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the Infuse-a-Port Explant Kit used for?
The Infuse-a-Port Explant Kit is a device used for the removal of implanted subcutaneous intravascular ports and catheters. It is designed to assist clinicians in safely explanting these long-term vascular access devices from patients in general hospital settings.
How is the Infuse-a-Port Explant Kit supplied and by whom?
The Infuse-a-Port Explant Kit is supplied by Intermedics/Infusaid, Inc. It is provided as a complete kit intended for use in general hospital settings, containing the necessary components for the removal of implanted ports and catheters.
What regulatory pathway was used for the Infuse-a-Port Explant Kit and when was it cleared?
The Infuse-a-Port Explant Kit received traditional 510(k) clearance under number K863296 on September 11, 1986. It was determined to be substantially equivalent to a legally marketed predicate device, which allowed it to be legally marketed in the United States.