INTRACOIL SELF-EXPANDING PERIPHERAL STENT— 510(k) K021563

Substantially Equivalent

Sulzer Intratherapeutics, Inc.

FDA 510(k) clearance K021563 for INTRACOIL SELF-EXPANDING PERIPHERAL STENT, Substantially Equivalent on 2002-05-31. Applicant: Sulzer Intratherapeutics, Inc..

Clearance details

Applicant: Sulzer Intratherapeutics, Inc.
Product code: 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

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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.