# K130382: Heartstring Iii Proximal Seal System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jun 5, 2013 after 111 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K800122 (1980). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080169: Heartstring Iii Proximal Seal System, Guidant Corporation, Cardiac Surgery (2008) Summary page 1.

## Most influential descendants
- K203307: VIOLA (2021), 1 descendant of its own
- K230248: VIOLA (2023), 0 descendants of its own

## Recalls of this device
- Aug 15, 2025 · Class II · Z-2588-2025: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide
- Aug 15, 2025 · Class II · Z-2587-2025: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide
- Aug 15, 2025 · Class II · Z-2586-2025: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide

## Indications for use
The HEARTSTRING III Proximal Seal System is intended for use by Physicians during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis to the aorta without application of an aortic clamp.

Source page: https://510kreport.com/device/K130382
Methodology: https://510kreport.com/methodology