Safelock Disposable Blood Collection Set, Disposable Blood Collection Set— 510(k) K151991

Substantially Equivalent

Jiangyin Caina Technology Co., Ltd.

FDA 510(k) clearance K151991 for Safelock Disposable Blood Collection Set, Disposable Blood Collection Set, Substantially Equivalent on 2015-12-11. Applicant: Jiangyin Caina Technology Co., Ltd..

Clearance details

Applicant: Jiangyin Caina Technology Co., Ltd.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2015-07-20
Decision date: 2015-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiangyin, CN

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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.