CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS— 510(k) K011487

Name: FDA 510(k) clearance K011487
Creator: U.S. Food and Drug Administration
Published: 2001-11-21

Substantially Equivalent

Somanetics Corp.

FDA 510(k) clearance K011487 for CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS, Substantially Equivalent on 2001-11-21. Applicant: Somanetics Corp.. Device class: 2.

Clearance details

Applicant: Somanetics Corp.
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2001-05-15
Decision date: 2001-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, US

Download summary PDF View on FDA.gov ↗

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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.