INTERCOSTAL LOCKABLE-DIRECTABLE PORT— 510(k) K011349

Name: FDA 510(k) clearance K011349
Creator: U.S. Food and Drug Administration
Published: 2001-10-05

Substantially Equivalent

Medcanica, Inc.

FDA 510(k) clearance K011349 for INTERCOSTAL LOCKABLE-DIRECTABLE PORT, Substantially Equivalent on 2001-10-05. Applicant: Medcanica, Inc.. Device class: 2.

Clearance details

Applicant: Medcanica, Inc.
Product code: Code DRC
Device class: Class 2
Regulation: 21 CFR 870.1390
Advisory panel: Cardiovascular
Date received: 2001-05-02
Decision date: 2001-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.