K872981

Substantially Equivalent

ACS INDEFLATOR PLUS (MODIFICATION #2)

Applicant: Advanced Cardiovascular Systems, Inc.
Product code: DXT
Advisory panel: Cardiovascular
Date received: 1987-07-31
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

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.