CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)— 510(k) K965059

Substantially Equivalent

Thomas Industries

FDA 510(k) clearance K965059 for CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243), Substantially Equivalent on 1997-03-04. Applicant: Thomas Industries.

Clearance details

Applicant: Thomas Industries
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1996-12-18
Decision date: 1997-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.