Y-TYPE BLOOD ADMINISTRATION SET— 510(k) K940074

Substantially Equivalent

Puritas Health Care, Inc.

FDA 510(k) clearance K940074 for Y-TYPE BLOOD ADMINISTRATION SET, Substantially Equivalent on 1994-04-21. Applicant: Puritas Health Care, Inc..

Clearance details

Applicant: Puritas Health Care, Inc.
Product code: Code BRZ
Advisory panel: General Hospital
Date received: 1994-01-06
Decision date: 1994-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Milford, CT, US

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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.