# K030231: Coronary Artery Perfusion Cannula with Self-Inflating Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Apr 18, 2003 after 86 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- 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) California Medical Laboratories, Inc. Aortic Root Cannula: named in the summary without a submission number

## Most influential descendants
- K162500: Ostial Sprit Cannulae (2017), 0 descendants of its own

## Recalls of this device
- Aug 12, 2016 · Class II · Z-2757-2016: The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.

## Indications for use
The Coronary Artery Perfusion Cannula With Self-Inflating Balloon is indicated for use in delivery of cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass surgery.

Source page: https://510kreport.com/device/K030231
Methodology: https://510kreport.com/methodology