# K973862: Port-a-Cath Low-Profile Implantable Access Systems

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Dec 29, 1997 after 81 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® P.A.S. PORT® II Implantable Access System: named in the summary without a submission number
- (no number) BardPort™ SlimPort™ Low Profile Port: 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-0864-04: 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-0863-04: 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 vascular access for injection (bolus) or infusion therapy and/or venous blood sampling.

Source page: https://510kreport.com/device/K973862
Methodology: https://510kreport.com/methodology