# K070020: Comcaset-P Safety IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pitango Medical, Ltd.
- Decided: Aug 16, 2007 after 225 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 K984059 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062108: Comcaset Safety IV Catheter, Pitango Medical, Ltd. (2006) Summary page 3.

## Indications for use
The ComCaSet-P Safety IV Catheter is indicated to sample blood, monitor blood pressure, or administer fluids intravenously. The ComCaSet-P 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-P 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 When the catheter hub and needle assembly components are withdrawn, the shielding mechanism is activated and the needle retracts into the shielding tube.

Source page: https://510kreport.com/device/K070020
Methodology: https://510kreport.com/methodology