CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH— 510(k) K120781

Substantially Equivalent

Fuji Systems Corp.

FDA 510(k) clearance K120781 for CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH, Substantially Equivalent on 2012-08-09. Applicant: Fuji Systems Corp..

Clearance details

Applicant: Fuji Systems Corp.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2012-03-15
Decision date: 2012-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.