RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)— 510(k) K973892

Name: FDA 510(k) clearance K973892
Creator: U.S. Food and Drug Administration
Published: 1998-05-18

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K973892 for RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE), Substantially Equivalent on 1998-05-18. Applicant: Rusch Intl.. Device class: 2.

Clearance details

Applicant: Rusch Intl.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1997-10-14
Decision date: 1998-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, US

Download summary PDF View on FDA.gov ↗

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K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER2003-06-17
K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS2003-03-28
K023964 — RUSCH MICROLARYNGEAL TUBE2002-12-23

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.