# K960350: Theraport Vascular Access System; Model 1001, 1002, 1601, 1602

- Pathway: 510(k) (Traditional)
- Applicant: Biocontrol Technology, Inc.
- Decided: Apr 15, 1996 after 81 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: none
- 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) Cook Pacemaker Corporation, VITAL-PORT® Vascular Access Port with Detached Catheter: named in the summary without a submission number
- (no number) Pharmacia Deltec, Inc., PORT-A-CATH® Implantable Access System: named in the summary without a submission number
- (no number) Therex, Inc., A-PORT® Implantable Vascular Access System: named in the summary without a submission number

## Indications for use
The theraPORT® is intended for use with patients that require repeated venous access for injection or infusion therapy and/or venous blood sampling.

Source page: https://510kreport.com/device/K960350
Methodology: https://510kreport.com/methodology