# K022880: Guidant Proximal Seal System, Models PSS-4500 & PS-4500

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Sep 13, 2002 after 14 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K800122 (1980). 2 ancestors in all.
4 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)
- K980128: Baladi Inverter with Coaxial Aortic Punch, Cardio Medical Solutions, Inc. (1998) Summary page 2.
- (no number) Novare Enclose anastomotic assist devices: named in the summary without a submission number

## Most influential descendants
- K080169: Heartstring Iii Proximal Seal System (2008), 3 descendants of its own
- K130382: Heartstring Iii Proximal Seal System (2013), 2 descendants of its own
- K203307: VIOLA (2021), 1 descendant of its own
- K230248: VIOLA (2023), 0 descendants of its own

## Recalls of this device
- May 5, 2010 · Not classified · Z-0940-2011: Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.

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

Source page: https://510kreport.com/device/K022880
Methodology: https://510kreport.com/methodology