Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter— 510(k) K200027

Substantially Equivalent

Jiangsu Caina Medical Co.,Ltd

FDA 510(k) clearance K200027 for Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter, Substantially Equivalent on 2020-09-09. Applicant: Jiangsu Caina Medical Co.,Ltd.

Clearance details

Applicant
Jiangsu Caina Medical Co.,Ltd
Product code
Code JKA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Jiangyin, 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.