Port-A-Cath
510(k) K832917
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832917 | Date28 Dec 1983 | 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- Withdrawn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
A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. It is used for repeated access to the vascular system for infusion of fluids, medications, or blood products, and for withdrawal of blood samples.
The device is supplied as an implantable system intended for long-term vascular access. It is regulated as a Class 2 medical device under product code LJT, with FDA 510(k) clearance K832917, and is indicated for use in general hospital settings.
Other devices from Pharmacia, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the PORT-A-CATH device used for?
The PORT-A-CATH is used for repeated access to the vascular system to infuse fluids, medications, or blood products, and for withdrawal of blood samples, providing long-term vascular access in general hospital settings.
How is the PORT-A-CATH supplied and intended for use?
The device is supplied as an implantable system intended for long-term vascular access, consisting of a subcutaneous implanted reservoir connected to a long-term intravascular catheter for repeated clinical use.
Is the PORT-A-CATH a single-use or reusable device?
The PORT-A-CATH is designed as an implantable system for long-term use, meaning it is not single-use but intended to remain implanted and accessed repeatedly over time via needle puncture of the septum.