# K253235: Introcan Safety® Deep Access XL IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: May 15, 2026 after 228 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
Longest line of descent: 4 generations back to K801941 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220626: Introcan Safety IV Catheter, B.Braun Medical, Inc. (2022) Summary page 5.

## Indications for use
Introcan Safety® Deep Access XL IV Catheter is a passive anti-needlestick device to provide venous or arterial access for the infusion of fluids, drugs, and or blood components, or to facilitate the placement of Vascular Access devices into the vascular system. The catheters may be used with power injectors at a maximum pressure of 325 psi with a luer lock connection only.

Source page: https://510kreport.com/device/K253235
Methodology: https://510kreport.com/methodology