PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI— 510(k) K896697

Substantially Equivalent

Deknatel, Inc.

FDA 510(k) clearance K896697 for PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI, Substantially Equivalent on 1990-02-08. Applicant: Deknatel, Inc..

Clearance details

Applicant: Deknatel, Inc.
Product code: Code KDQ
Advisory panel: General Hospital
Date received: 1989-11-28
Decision date: 1990-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose-Heredia, CR

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Adverse events under product code KDQ

product code KDQ

Death: 8
Malfunction: 637
Total: 645

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.