# K062108: Comcaset Safety IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pitango Medical, Ltd.
- Decided: Aug 8, 2006 after 15 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: 1 generation back to K984059 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984059: Angiocath Autoguard Catheter, Insyte Autoguard Catheter, Bd Becton Dickinson Vacutainer Systems Preanalytic (1999) Summary page 3.

## Most influential descendants
- K070020: Comcaset-P Safety IV Catheter (2007), 0 descendants of its own

## Indications for use
The ComCaSet Safety IV Catheter is indicated to sample blood, monitor blood pressure, or administer fluids intravenously. The ComCaSet Safety IV Catheter may be used for any patient population with consideration given to adequacy of the vascular anatomy appropriateness for the solution being administered and duration of the therapy. The ComCaSet Safety IV Catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the catheter hub and needle assembly components are withdrawn, the user activates the shielding mechanism and the needle retracts into the shielding tube.

Source page: https://510kreport.com/device/K062108
Methodology: https://510kreport.com/methodology