# K980566: Vaxess Peripherally Inserted Central Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 14, 1998 after 213 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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) PICC catheter offered by Cook Inc.: named in the summary without a submission number
- (no number) PICC catheter offered by Luther Medical: named in the summary without a submission number

## Indications for use
The PICC catheter system is designed for use when central venous catheterization or prolonged intravenous administration of fluids, medications, and/or nutritional therapy is prescribed. A variety of insertion sites may be utilized, depending upon the patient involved and the catheter size selected. While any vessel suitable for insertion may be used, the basilic vein is the most commonly used vein. Location of the distal catheter tip must provide maximum dilution for whatever therapy becomes necessary and assurance of a continued, uncompromised vascular access.

Source page: https://510kreport.com/device/K980566
Methodology: https://510kreport.com/methodology