K021563

Substantially Equivalent

INTRACOIL SELF-EXPANDING PERIPHERAL STENT

Applicant: Sulzer Intratherapeutics, Inc.
Product code: JCT
Advisory panel: General, Plastic Surgery
Date received: 2002-05-13
Decision date: 2002-05-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint Paul, MN, US

Adverse events under product code JCT

product code JCT

Death: 20
Injury: 211
Other: 1
Total: 232

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.