# K112683: Smi Cardiovascular Pach

- Pathway: 510(k) (Traditional)
- Applicant: Solimas Medical, Inc.
- Decided: Dec 14, 2011 after 90 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
Longest line of descent: 2 generations back to K811841 (1981). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984526: Acuseal Cardiovascular Patch, W. L. Gore & Associates, Inc. (1999) Summary page 1.
- K962342: Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch, Meadox Medicals, Div. Boston Scientific Corp. (1996) Summary page 1.
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture, Genzyme Corp. (2002) Summary page 1.
- (no number) DeBakey Elastic Knit Fabric: named in the summary without a submission number

## Most influential descendants
- K122105: Smi Cardiovascular Patch (2012), 0 descendants of its own

## Indications for use
The Salinas Medical, Inc. SMI Cardiovascular Patch is indicated for cardiovascular patching.

Source page: https://510kreport.com/device/K112683
Methodology: https://510kreport.com/methodology