# K980493: I.V. Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Apr 28, 1998 after 78 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) CRITIKON OCR I.V. Catheter: named in the summary without a submission number
- (no number) Punctur-Guard Blood Collection Needle: named in the summary without a submission number

## Indications for use
A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically as the catheter is threaded into the vessel.

Source page: https://510kreport.com/device/K980493
Methodology: https://510kreport.com/methodology