# K020693: Aortic Cannula, Metal J-Tip (24FR) Model #CF00100; Aortic Cannula, Plastic J-Tip (24FR) Model #CF00101

- Pathway: 510(k) (Traditional)
- Applicant: Embol-X, Inc.
- Decided: Sep 5, 2002 after 185 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) EMBOL-XB Introducer: named in the summary without a submission number
- (no number) DLPR Curved Metal Tip Arterial Cannula: named in the summary without a submission number

## Most influential descendants
- K141465: Cardiogard Emboli Protection Cannula (2015), 1 descendant of its own
- K182302: CardioGard Emboli Protection Cannula (2019), 0 descendants of its own

## Recalls of this device
- Nov 19, 2004 · Not classified · Z-0306-05: Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.

## Indications for use
The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascending aorta during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

Source page: https://510kreport.com/device/K020693
Methodology: https://510kreport.com/methodology