RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION— 510(k) K953963

Name: FDA 510(k) clearance K953963
Creator: U.S. Food and Drug Administration
Published: 1995-11-27

Substantially Equivalent

Rusch, Inc.

FDA 510(k) clearance K953963 for RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION, Substantially Equivalent on 1995-11-27. Applicant: Rusch, Inc.. Device class: 2.

Clearance details

Applicant: Rusch, Inc.
Product code: Code BTS
Device class: Class 2
Regulation: 21 CFR 868.5720
Advisory panel: Anesthesiology
Date received: 1995-08-22
Decision date: 1995-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, US

Download summary PDF View on FDA.gov ↗

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K833297 — BRONCHOSCOPY TUBE W/ULTRA LOCUFF1983-12-27
K771219 — BRONCHO-CATH1977-08-04

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Adverse events under product code BTS

product code BTS

Death: 2
Malfunction: 877
Total: 879

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.