HICALIQ IVH BAG— 510(k) K771432

Substantially Equivalent

Terumo America, Inc.

FDA 510(k) clearance K771432 for HICALIQ IVH BAG, Substantially Equivalent on 1977-09-28. Applicant: Terumo America, Inc..

Clearance details

Applicant: Terumo America, Inc.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 1977-08-01
Decision date: 1977-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.