BRONCHO-CATH— 510(k) K771219

Name: FDA 510(k) clearance K771219
Creator: U.S. Food and Drug Administration
Published: 1977-08-04

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K771219 for BRONCHO-CATH, Substantially Equivalent on 1977-08-04. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code BTS
Device class: Class 2
Regulation: 21 CFR 868.5720
Advisory panel: Anesthesiology
Date received: 1977-07-05
Decision date: 1977-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTS

view all

K953963 — RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION1995-11-27
K951091 — RUSCH ENDOBRONCHIAL TUBE SETS1995-06-08
K902116 — MODIFIED ENDOBRONCHIAL TUBE1990-08-03
K834565 — ENDOBRONCHIAL TWIN LUMEN TUBE1984-01-17
K833297 — BRONCHOSCOPY TUBE W/ULTRA LOCUFF1983-12-27

More clearances from Mallinckrodt Critical Care

view all

K880343 — BURNEY GALLBLADDER CATHETER KIT1989-05-01
K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR1988-02-02
K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE1988-01-29
K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR1988-01-06
K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)1987-11-06

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.