Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder— 510(k) K232881

Substantially Equivalent

Jiangsu Kangbao Medical Equipment Co., Ltd.

FDA 510(k) clearance K232881 for Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder, Substantially Equivalent on 2023-12-22. Applicant: Jiangsu Kangbao Medical Equipment Co., Ltd..

Clearance details

Applicant
Jiangsu Kangbao Medical Equipment Co., Ltd.
Product code
Code JKA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yangzhou, CN
Download summary PDFView 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, through . 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.