VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM— 510(k) K012544

Substantially Equivalent

Vascular Architects, Inc.

FDA 510(k) clearance K012544 for VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM, Substantially Equivalent on 2001-11-15. Applicant: Vascular Architects, Inc..

Clearance details

Applicant: Vascular Architects, Inc.
Product code: Code JCT
Advisory panel: General, Plastic Surgery
Date received: 2001-08-07
Decision date: 2001-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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.