OLYMPUS B5-2C/B7-2C BALLOON CATHETER— 510(k) K962901

Name: FDA 510(k) clearance K962901
Creator: U.S. Food and Drug Administration
Published: 1996-08-20

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K962901 for OLYMPUS B5-2C/B7-2C BALLOON CATHETER, Substantially Equivalent on 1996-08-20. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 1996-07-25
Decision date: 1996-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.