IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)— 510(k) K955380

Name: FDA 510(k) clearance K955380
Creator: U.S. Food and Drug Administration
Published: 1996-05-14

Substantially Equivalent

International Biophysics Corp.

FDA 510(k) clearance K955380 for IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4), Substantially Equivalent on 1996-05-14. Applicant: International Biophysics Corp.. Device class: 2.

Clearance details

Applicant: International Biophysics Corp.
Product code: Code DRY
Device class: Class 2
Regulation: 21 CFR 870.4330
Advisory panel: Cardiovascular
Date received: 1995-11-24
Decision date: 1996-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRY

product code DRY

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.