ACS INDEFLATOR PLUS (MODIFICATION #2)— 510(k) K872981

Substantially Equivalent

Advanced Cardiovascular Systems, Inc.

FDA 510(k) clearance K872981 for ACS INDEFLATOR PLUS (MODIFICATION #2), Substantially Equivalent on 1987-10-20. Applicant: Advanced Cardiovascular Systems, Inc..

Clearance details

Applicant: Advanced Cardiovascular Systems, Inc.
Product code: 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

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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.