STATLOCK CV— 510(k) K943147

Name: FDA 510(k) clearance K943147
Creator: U.S. Food and Drug Administration
Published: 1994-09-29

Substantially Equivalent

Venetec, Inc.

FDA 510(k) clearance K943147 for STATLOCK CV, Substantially Equivalent on 1994-09-29. Applicant: Venetec, Inc.. Device class: 1.

Clearance details

Applicant: Venetec, Inc.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1994-06-30
Decision date: 1994-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.