Vein Clamps, Artery Clamps— 510(k) K161315

Substantially Equivalent

Aros Surgical Instruments Corporation

FDA 510(k) clearance K161315 for Vein Clamps, Artery Clamps, Substantially Equivalent on 2016-08-18. Applicant: Aros Surgical Instruments Corporation.

Clearance details

Applicant: Aros Surgical Instruments Corporation
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2016-05-11
Decision date: 2016-08-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.