# K970669: Aeroquip Safestart IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Aeroquip Medical Products
- Decided: Aug 1, 1997 after 158 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 PROTECTIV™: named in the summary without a submission number
- (no number) Low Profile Safsite Y-Site: named in the summary without a submission number

## Indications for use
The Aeroquip SafeStart™ IV Catheter is a sterile, non-pyrogenic, disposable peripheral vascular access catheter intended to provide peripheral venous access per CDC guidelines without the spillage of blood when accessing a vein or artery. It is intended to allow administration of drugs and fluids into patients via a standard luer connection. The Aeroquip SafeStart™ IV Catheter permits for any type of intravenous fluid administration (continuous and intermittent) or withdrawal of fluids.

Source page: https://510kreport.com/device/K970669
Methodology: https://510kreport.com/methodology