10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE— 510(k) K871360

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K871360 for 10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE, Substantially Equivalent on 1987-04-29. Applicant: Quinton, Inc..

Clearance details

Applicant: Quinton, Inc.
Product code: Code MPB
Advisory panel: Gastroenterology, Urology
Date received: 1987-04-06
Decision date: 1987-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

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Adverse events under product code MPB

product code MPB

Death: 18
Malfunction: 1,042
Total: 1,060

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.