510(k) K892530— CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH

Substantially Equivalent

Arrow Intl., Inc.

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1989-04-11
Decision date: 1989-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.