SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE— 510(k) K872472

Substantially Equivalent

Angiomedics, Inc.

FDA 510(k) clearance K872472 for SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE, Substantially Equivalent on 1987-09-14. Applicant: Angiomedics, Inc..

Clearance details

Applicant: Angiomedics, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1987-06-23
Decision date: 1987-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.