K230080

Substantially Equivalent

Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood

Applicant: Yangzhou Medline Industry, Co., Ltd.
Product code: JKA
Advisory panel: Clinical Chemistry
Date received: 2023-01-11
Decision date: 2023-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yangzhou, CN

Download summary PDF View on FDA.gov ↗

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.