# K122105: Smi Cardiovascular Patch

- Pathway: 510(k) (Special)
- Applicant: Solinas Medical, Inc.
- Decided: Dec 7, 2012 after 143 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: 3 generations back to K811841 (1981). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112683: Smi Cardiovascular Pach, Solimas Medical, Inc. (2011) Summary page 1.

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

Source page: https://510kreport.com/device/K122105
Methodology: https://510kreport.com/methodology