K092097

Substantially Equivalent

A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH

Applicant: A.B. Korkor Medical, Inc.
Product code: DYB
Advisory panel: Cardiovascular
Date received: 2009-07-14
Decision date: 2010-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Barrington, IL, US

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.