ARROW QUADPOLAR MAPPING/PACING CATHETER— 510(k) K911065

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K911065 for ARROW QUADPOLAR MAPPING/PACING CATHETER, Substantially Equivalent on 1992-06-18. Applicant: Arrow Intl., Inc..

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1991-03-13
Decision date: 1992-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

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Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.