# K163358: Introcan Safety 3 Closed IV Catheter

- Pathway: 510(k) (Special)
- Applicant: B.Braun Melsungen AG
- Decided: Apr 28, 2017 after 149 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). 11 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111236: Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1, B.Braun Melsungen AG (2011) Summary page 4.

## Most influential descendants
- K182870: Introcan Safety 3 Closed IV Catheter (2019), 8 descendants of its own
- K192676: Introcan Safety 2 IV Catheter 18-24 gauge (2020), 6 descendants of its own
- K213664: B. Braun Introcan Safety 2 IV Catheter (2022), 3 descendants of its own
- K231401: Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva (2023), 1 descendant of its own
- K220756: Introcan Safety 2 IV Catheter (2022), 1 descendant of its own

## Indications for use
Introcan Safety® 3 Closed Intravascular 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.

Source page: https://510kreport.com/device/K163358
Methodology: https://510kreport.com/methodology