KIT PAK SUCTION CATHETER KIT— 510(k) K885131

Substantially Equivalent

Kit Pak, Inc.

FDA 510(k) clearance K885131 for KIT PAK SUCTION CATHETER KIT, Substantially Equivalent on 1989-01-09. Applicant: Kit Pak, Inc..

Clearance details

Applicant: Kit Pak, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1988-12-12
Decision date: 1989-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Grove Village, IL, 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.