# K980631: Embol-X Aortic Occlusion and Cardioplegia Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Embol-X, Inc.
- Decided: Feb 2, 1999 after 349 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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 K790565 (1979). 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)
- K962510: Heartport Endoaortic Clamp, Heartport, Inc. (1996) Summary page 2.
- K832386: Percluder DL Occluding Balloon, Datascope Corp. (1983). Our OCR of the scanned summary read K832356, FDA’s number for Portable Operat. RM. Monitors HS30/40 (Medtel Pty., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Datascope’s Precluder DL Occluding Balloon”.
- K790565: Aortic Root Cannula, Dlp, Inc. (1979) Summary page 2.
- K896636: Rmi Anteplegia Cannula, Research Medical, Inc. (1990) Summary page 2.

## Indications for use
The EMBOL-X Aortic Occlusion and Cardioplegia Cannula is intended for use during cardiopulmonary bypass (CPB) procedures to: (1) occlude the ascending aorta, (2) deliver cardioplegia solution, and (3) vent the aortic root.

Source page: https://510kreport.com/device/K980631
Methodology: https://510kreport.com/methodology