A.C.I. TRACH TIE— 510(k) K882891

Name: FDA 510(k) clearance K882891
Creator: U.S. Food and Drug Administration
Published: 1988-09-19

Substantially Equivalent

Auxiliary Care, Inc.

FDA 510(k) clearance K882891 for A.C.I. TRACH TIE, Substantially Equivalent on 1988-09-19. Applicant: Auxiliary Care, Inc.. Device class: 1.

Clearance details

Applicant: Auxiliary Care, Inc.
Product code: Code CBH
Device class: Class 1
Regulation: 21 CFR 868.5770
Advisory panel: Anesthesiology
Date received: 1988-07-11
Decision date: 1988-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coral Gables, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBH

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K140097 — AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM2014-09-24
K964399 — DALE ENDOTRACHEAL TUBE HOLDER 270/2801997-01-28
K942529 — HCI TUBE STABILIZER1995-06-14
K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS1995-04-24
K950930 — TRACHE-TITE1995-03-22

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.