# K031922: Captiva Blood Containment Device CN100, CAN19T71W

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 1, 2003 after 100 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Novoste PulsePlus Blood Containment Device: named in the summary without a submission number

## Indications for use
The Captiva Blood Containment Device is intended for blood containment during vascular access procedures. Upon entering the vessel, the Captiva Blood Containment Device provides visualization of flashback and containment of blood within a sealed chamber. It also allows placement of a guidewire through the device for subsequent catheterization.

Source page: https://510kreport.com/device/K031922
Methodology: https://510kreport.com/methodology