SUCTION CATHETER KIT— 510(k) K863497

Substantially Equivalent

Welmed Systems, Inc.

FDA 510(k) clearance K863497 for SUCTION CATHETER KIT, Substantially Equivalent on 1986-10-06. Applicant: Welmed Systems, Inc..

Clearance details

Applicant: Welmed Systems, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1986-09-09
Decision date: 1986-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Swanzey, NH, 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.