CAROTID BYPASS SHUNT— 510(k) K860742

Name: FDA 510(k) clearance K860742
Creator: U.S. Food and Drug Administration
Published: 1986-05-28

Substantially Equivalent

Clincal Instruments Corp.

FDA 510(k) clearance K860742 for CAROTID BYPASS SHUNT, Substantially Equivalent on 1986-05-28. Applicant: Clincal Instruments Corp.. Device class: 2.

Clearance details

Applicant: Clincal Instruments Corp.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
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 ↗

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More clearances from Clincal Instruments Corp.

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K902327 — EMBOLECTOMY CATHETER1991-02-25
K860743 — CAROTID BYPASS SHUNT WITH SAMPLING ARM1986-05-28
K852704 — TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT1985-11-26
K844918 — OCCLUSION & OCCLUSION-IRRIGATION1985-08-05
K821220 — MULTILUMEN INTRAVENOUS INFUSION CATHETER1982-07-09

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.