DISPOSABLE MANIFOLD SET— 510(k) K832657

Name: FDA 510(k) clearance K832657
Creator: U.S. Food and Drug Administration
Published: 1983-11-07

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K832657 for DISPOSABLE MANIFOLD SET, Substantially Equivalent on 1983-11-07. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code DRS
Device class: Class 2
Regulation: 21 CFR 870.2850
Advisory panel: Cardiovascular
Date received: 1983-08-08
Decision date: 1983-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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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 DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.