# K974471: Port-a-Cath- II Dual-Lumen Low Profile System, Port-a-Cath II Dual Lumen Low Profile System with Introducer Set, Port-a

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Jan 22, 1998 after 57 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PORT-A-CATH® II Dual-Lumen Implantable Access Systems: named in the summary without a submission number
- (no number) LifePort® Low Profile Dual Lumen System: named in the summary without a submission number
- (no number) PORT-A-CATH® I Dual-Lumen Systems: named in the summary without a submission number

## Recalls of this device
- Dec 4, 2017 · Class II · Z-1073-2018: Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. T
- Mar 29, 2004 · Not classified · Z-0877-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri
- Mar 29, 2004 · Not classified · Z-0878-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri

## Indications for use
A system is indicated when a patient requires repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling

Source page: https://510kreport.com/device/K974471
Methodology: https://510kreport.com/methodology