PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,— 510(k) K102007

Substantially Equivalent

Life-Tech, Inc.

FDA 510(k) clearance K102007 for PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,, Substantially Equivalent on 2010-12-22. Applicant: Life-Tech, Inc..

Clearance details

Applicant: Life-Tech, Inc.
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 2010-07-16
Decision date: 2010-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Stafford, TX, US

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Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.