# K993288: Sulzer Carbomedics Cardiofix Pericardium

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Carbomedics, Inc.
- Decided: Dec 29, 1999 after 89 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 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) Bio-Vascular Peri-Guard Pericardium: named in the summary without a submission number

## Most influential descendants
- K031785: Macropore Cardio-Wrap (TS) (2003), 1 descendant of its own
- K162506: PhotoFix Decellularized Bovine Pericardium (2017), 0 descendants of its own
- K090637: Cardio-Wrap (2010), 0 descendants of its own
- K081438: Matracell Decellularized Pulmonary Artery Patch Allograft (2008), 0 descendants of its own

## Indications for use
Sulzer Carbomedics CardioFix™ Pericardium is indicated for the following uses: Intracardiac Repair » Ventricular repair using a reinforced patch technique (i.e., minimum of double thickness). » Atrial Repair. Great vessel repair and suture line buttressing using a reinforced patch technique (i.e., minimum of double thickness) for applications exposed to peak systolic pressure. Pericardial Closure.

Source page: https://510kreport.com/device/K993288
Methodology: https://510kreport.com/methodology