# K041345: Protectiv Jelco Safety I.V. Catheter, Model 3600 Series

- Pathway: 510(k) (Traditional)
- Applicant: Medix, Inc.
- Decided: Jul 22, 2004 after 63 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 needle guard that automatically locks over the needle as the catheter is threaded into the vessel reduces the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. 16 to 24 gauge catheters may be used with power injectors up to 300 psi.

Source page: https://510kreport.com/device/K041345
Methodology: https://510kreport.com/methodology