CATHETER, TRANSLUMINAL BALLOON— 510(k) K781772

Name: FDA 510(k) clearance K781772
Creator: U.S. Food and Drug Administration
Published: 1979-03-06

Substantially Equivalent

Medi-Tech, Inc.

FDA 510(k) clearance K781772 for CATHETER, TRANSLUMINAL BALLOON, Substantially Equivalent on 1979-03-06. Applicant: Medi-Tech, Inc.. Device class: 1.

Clearance details

Applicant: Medi-Tech, Inc.
Product code: Code GBA
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1978-10-16
Decision date: 1979-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GBA

product code GBA

Death: 2
Total: 2

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.