LASER RESISTANT TRACHEAL TUBE— 510(k) K897046

Name: FDA 510(k) clearance K897046
Creator: U.S. Food and Drug Administration
Published: 1990-03-23

Substantially Equivalent

Sheridan Catheter Corp.

FDA 510(k) clearance K897046 for LASER RESISTANT TRACHEAL TUBE, Substantially Equivalent on 1990-03-23. Applicant: Sheridan Catheter Corp.. Device class: 2.

Clearance details

Applicant: Sheridan Catheter Corp.
Product code: Code CBI
Device class: Class 2
Regulation: 21 CFR 868.5740
Advisory panel: Anesthesiology
Date received: 1989-12-18
Decision date: 1990-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Argyle, NY, US

Download summary PDF View on FDA.gov ↗

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K884765 — CLINICAL ELECTRONIC THERMOMETERS1989-02-16
K882918 — KIM NASO-INTESTINAL TUBE1988-12-05
K882127 — CLINICAL ELECTRONIC THERMOMETERS1988-08-04

Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

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.