K072783

Substantially Equivalent

SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH

Applicant: Smiths Medical Asd, Inc.
Product code: JKA
Advisory panel: Clinical Chemistry
Date received: 2007-10-01
Decision date: 2007-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.