K021462

Substantially Equivalent

ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840

Applicant: Arrow Intl., Inc.
Product code: DSP
Advisory panel: Cardiovascular
Date received: 2002-05-07
Decision date: 2002-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Everett, MA, US

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Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

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.