TUBES, LUKENS, TOMAS— 510(k) K781234

Name: FDA 510(k) clearance K781234
Creator: U.S. Food and Drug Administration
Published: 1978-08-10

Substantially Equivalent

Ludwig Medical, Inc.

FDA 510(k) clearance K781234 for TUBES, LUKENS, TOMAS, Substantially Equivalent on 1978-08-10. Applicant: Ludwig Medical, Inc.. Device class: 2.

Clearance details

Applicant: Ludwig Medical, Inc.
Product code: Code KDQ
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1978-07-19
Decision date: 1978-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K043582 — OCEAN CHEST DRAIN2005-01-21
K984496 — ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN1999-05-05
K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR1996-08-28

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.