BALLOON RETENTION CHEST CATHETER— 510(k) K802025

Name: FDA 510(k) clearance K802025
Creator: U.S. Food and Drug Administration
Published: 1980-09-26

Substantially Equivalent

Loseff Medical Designers, Ltd.

FDA 510(k) clearance K802025 for BALLOON RETENTION CHEST CATHETER, Substantially Equivalent on 1980-09-26. Applicant: Loseff Medical Designers, Ltd.. Device class: 1.

Clearance details

Applicant: Loseff Medical Designers, Ltd.
Product code: Code GBA
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1980-08-20
Decision date: 1980-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K801349 — LOSEFF BALLOON TYPE SELF-RETENTION WOUND1980-08-07

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.