PENNINE SUCTION CATHETERS— 510(k) K852080

Substantially Equivalent

Pennine Medical , Ltd.

FDA 510(k) clearance K852080 for PENNINE SUCTION CATHETERS, Substantially Equivalent on 1985-06-03. Applicant: Pennine Medical , Ltd..

Clearance details

Applicant: Pennine Medical , Ltd.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1985-05-13
Decision date: 1985-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, US

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Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.