CAROTID BYPASS SHUNT— 510(k) K860742

Substantially Equivalent

Clincal Instruments Corp.

FDA 510(k) clearance K860742 for CAROTID BYPASS SHUNT, Substantially Equivalent on 1986-05-28. Applicant: Clincal Instruments Corp..

Clearance details

Applicant: Clincal Instruments Corp.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1986-02-27
Decision date: 1986-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dudley, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.