# K012143: 24 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524

- Pathway: 510(k) (Special)
- Applicant: Medtronic Cardiac Surgical Products
- Decided: Oct 24, 2001 after 106 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831591 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K834352: Adult Vent Catheter, Dlp, Inc. (1984) Summary page 2.
- K834039: Infant Vent Catheter 12001 W/Side Vent, Dlp, Inc. (1984) Summary page 3.
- K831591: Aortic Root Cannula W/Integral Press, Dlp, Inc. (1983) Summary page 2.

## Indications for use
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for venting the left heart during cardiopulmonary bypass surgery.

Source page: https://510kreport.com/device/K012143
Methodology: https://510kreport.com/methodology