510(k) K882891— A.C.I. TRACH TIE

Substantially Equivalent

Auxiliary Care, Inc.

Clearance details

Applicant: Auxiliary Care, Inc.
Product code: Code CBH
Advisory panel: Anesthesiology
Date received: 1988-07-11
Decision date: 1988-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coral Gables, FL, US

Adverse events under product code CBH

product code CBH

Death: 7
Total: 7

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.