DRAIN/PRIMING/RECIRCULATION BAG— 510(k) K913361

Substantially Equivalent

Haemotronic, Inc.

FDA 510(k) clearance K913361 for DRAIN/PRIMING/RECIRCULATION BAG, Substantially Equivalent on 1992-03-30. Applicant: Haemotronic, Inc..

Clearance details

Applicant: Haemotronic, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1991-07-29
Decision date: 1992-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.