VASCULAR CLAMP— 510(k) K881158

Substantially Equivalent

T. Korossurgical Instruments Corp.

FDA 510(k) clearance K881158 for VASCULAR CLAMP, Substantially Equivalent on 1988-06-20. Applicant: T. Korossurgical Instruments Corp..

Clearance details

Applicant: T. Korossurgical Instruments Corp.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 1988-03-18
Decision date: 1988-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moorepark, CA, US

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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.