510(k) K882501— ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100

Substantially Equivalent

Terumo Medical Corp.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code GIM
Advisory panel: Clinical Chemistry
Date received: 1988-06-17
Decision date: 1988-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Adverse events under product code GIM

product code GIM

Malfunction: 1,325
Total: 1,325

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.