PROLONG— 510(k) K081864

Substantially Equivalent

Life-Tech, Inc.

FDA 510(k) clearance K081864 for PROLONG, Substantially Equivalent on 2008-09-25. Applicant: Life-Tech, Inc..

Clearance details

Applicant: Life-Tech, Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2008-07-01
Decision date: 2008-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Stafford, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

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.