# K241845: Introcan Safety® 2 IV Catheter

- Pathway: 510(k) (Special)
- Applicant: B.Braun Medical, Inc.
- Decided: Jul 26, 2024 after 30 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: 9 generations back to K801941 (1980). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220756: Introcan Safety 2 IV Catheter, B.Braun Medical, Inc. (2022) Summary page 5.

## Indications for use
The Introcan Safety@ 2 IV Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids and blood intravascularly. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a luer lock connection only.

Source page: https://510kreport.com/device/K241845
Methodology: https://510kreport.com/methodology