# K200373: Deltaven Fast Flash Closed I.V. Catheter Systems

- Pathway: 510(k) (Traditional)
- Applicant: Delta Med Spa
- Decided: Aug 26, 2020 after 194 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K032843 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171530: Deltaven XiV Max, Deltaven XiV Max FF, Delta Med Spa (2017) Summary page 4.

## Recalls of this device
- Jun 21, 2021 · Class II · Z-2296-2021: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- Jun 21, 2021 · Class II · Z-2305-2021: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

## Indications for use
Deltaven Fast Flash Closed I.V. Catheter systems are catheters for short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly. Deltaven Fast Flash Closed I.V. Catheter systems are equipped with a passive system for the prevention of accidental needlestick injuries. Blood is contained within the device during the catheter insertion process, aiding the prevention of blood exposure. The device can be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. Deltaven Fast Flash Closed I.V. Catheter systems 16-24 gauge catheters are suitable for use with pressure injectors rated for a maximum of 330 psi when the access ports and stopcocks are removed and a direct connection is made with the proximal luer lock connector. Deltaven Fast Flash Closed I.V. Catheter systems 26G are not suitable for the administration at high pressure.

Source page: https://510kreport.com/device/K200373
Methodology: https://510kreport.com/methodology