SABRATEK SABSIL SETS— 510(k) K944293

Substantially Equivalent

Sabratek Corp.

FDA 510(k) clearance K944293 for SABRATEK SABSIL SETS, Substantially Equivalent on 1995-03-23. Applicant: Sabratek Corp..

Clearance details

Applicant: Sabratek Corp.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1994-09-02
Decision date: 1995-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.