K922402

Substantially Equivalent

4 SURE TM ENTERAL FEEDING BAG

Applicant: Boston Pacific Medical, Inc.
Product code: FPD
Advisory panel: Gastroenterology, Urology
Date received: 1992-05-21
Decision date: 1994-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.