SMI CARDIOVASCULAR PACH— 510(k) K112683

Name: FDA 510(k) clearance K112683
Creator: U.S. Food and Drug Administration
Published: 2011-12-14

Substantially Equivalent

Solimas Medical, Inc.

FDA 510(k) clearance K112683 for SMI CARDIOVASCULAR PACH, Substantially Equivalent on 2011-12-14. Applicant: Solimas Medical, Inc.. Device class: 2.

Clearance details

Applicant: Solimas Medical, Inc.
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2011-09-15
Decision date: 2011-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunny Vale, CA, US

Download summary PDF View on FDA.gov ↗

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K152127 — CorMatrix Tyke2016-02-04

Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.