# K896819: Vamp Venous/Arterial Blood Management Protection

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jan 19, 1990 after 46 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 4, 2023 · Class II · Z-0414-2024: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
- Jan 30, 2013 · Class II · Z-1146-2013: The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.

Source page: https://510kreport.com/device/K896819
Methodology: https://510kreport.com/methodology