# K834352: Adult Vent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Jan 27, 1984 after 45 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K200289: Michler-Kapp Cardiovascular Vent Catheter (2021), 0 descendants of its own
- K170488: Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr (2017), 0 descendants of its own
- K012143: 24 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524 (2001), 0 descendants of its own

## Recalls of this device
- Aug 24, 2021 · Class II · Z-2504-2021: Potential for a wire protrusion through the left heart vent catheter tip
- Aug 24, 2021 · Class II · Z-2505-2021: Potential for a wire protrusion through the left heart vent catheter tip

Source page: https://510kreport.com/device/K834352
Methodology: https://510kreport.com/methodology