# K181684: VAMP Plus Venous/Arterial Blood Management Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Nov 8, 2018 after 135 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K925638 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161962: VAMP Venous/Arterial Blood Management Protection System, Edwards Lifesciences, LLC (2016) Summary page 4.
- K173586: VAMP Venous/Arterial Blood Management Protection System, Edwards Lifesciences, LLC (2018) Summary page 4.

## 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.

## Indications for use
To be used only for blood withdrawal. The blood sampling system is indicated for use on patients requiring periodic withdrawal of blood samples from arterial and central line catheters, including peripherally inserted central catheters and central venous catheters, which are attached to pressure monitoring lines.

Source page: https://510kreport.com/device/K181684
Methodology: https://510kreport.com/methodology