# K981601: California Medical Laboratories Inc. Malleable Vent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Jul 28, 1998 after 85 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Research Medical, Inc. Left Ventricular Vent Catheter: named in the summary without a submission number
- (no number) DLP, Inc. Left Ventricular Malleable Vent Catheter: named in the summary without a submission number

## Most influential descendants
- 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

## Indications for use
The Malleable Vent Catheter is indicated for use during cardiopulmonary bypass surgery to vent/drain the left ventricle.

Source page: https://510kreport.com/device/K981601
Methodology: https://510kreport.com/methodology