PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F— 510(k) K960715

Substantially Equivalent

Ideas For Medicine, Inc.

FDA 510(k) clearance K960715 for PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F, Substantially Equivalent on 1996-09-09. Applicant: Ideas For Medicine, Inc..

Clearance details

Applicant: Ideas For Medicine, Inc.
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 1996-02-21
Decision date: 1996-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.