A2 Port, Dual Lumen System With Detached Catheter, Catalog # AP-01518
510(k) K963684
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK963684 | Date24 Oct 1996 | 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- Withdrawn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
- Full name
- A2 Port, Dual Lumen System with Detached Catheter, Catalog # Ap-01518 (Modified)
- 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, 20 Sep 2026
The A2 Port, Dual Lumen System With Detached Catheter is a subcutaneous, implanted port designed for repeated vascular access. It features a portal body with a resealable septum and dual non-communicating lumens, enabling simultaneous infusion of fluids and medications or blood sampling through separate channels. This configuration supports long-term intravenous therapy while minimizing infection risk by reducing access points.
This device is supplied sterile and intended for single-use implantation under sterile conditions. It is classified as a Class II medical device under FDA regulations and has been cleared via a 510(k) pathway as substantially equivalent to predicate devices. The system includes a detachable catheter for intravascular placement, requiring surgical implantation and subsequent connection to the port. Compatibility with MRI is not specified, and proper storage involves maintaining sterility until use.