ARROW-TREROTOLA PTD CATHETER— 510(k) K970080

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K970080 for ARROW-TREROTOLA PTD CATHETER, Substantially Equivalent on 1997-07-25. Applicant: Arrow Intl., Inc..

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 1997-01-09
Decision date: 1997-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

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Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.