# K143610: BD Intima II Closed IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Apr 9, 2015 after 111 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: 2 generations back to K833657 (1983). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100775: BD Intima II Closed IV Catheter, Becton Dickinson Infusion Therapy Systems, Inc. (2010) Summary page 4.

## Most influential descendants
- K172204: BD Intima II PLUS Closed IV Catheter System (2017), 1 descendant of its own
- K200891: BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System (2021), 0 descendants of its own

## Indications for use
The BD Intima II Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.

Source page: https://510kreport.com/device/K143610
Methodology: https://510kreport.com/methodology
