# K170488: Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr

- Pathway: 510(k) (Traditional)
- Applicant: Surge Cardiovascular
- Decided: Aug 10, 2017 after 174 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
Longest line of descent: 2 generations back to K770430 (1977). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964194: Chase Curved Left Heart Vent Catheter, Chase Medical, Inc. (1997) Summary page 4.
- K834352: Adult Vent Catheter, Dlp, Inc. (1984) Summary page 4.
- K981601: California Medical Laboratories Inc. Malleable Vent Catheter, Sorin Group Italia S.R.L. (1998) Summary page 4.

## Indications for use
The Peak Left Ventricular Vent Cannula is indicated for use in venting the left ventricle during cardiopulmonary bypass procedures for durations up to 6 hours. The entrance is made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve.

Source page: https://510kreport.com/device/K170488
Methodology: https://510kreport.com/methodology