Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2— 510(k) K921595

Substantially Equivalent

Haemotronic, Inc.

FDA 510(k) clearance K921595 for Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2, Substantially Equivalent on 1992-12-24. Applicant: Haemotronic, Inc..

Clearance details

Applicant: Haemotronic, Inc.
Product code: Code BRZ
Advisory panel: General Hospital
Date received: 1992-04-03
Decision date: 1992-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BRZ

product code BRZ

Malfunction: 458
Total: 458

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.