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

Name: FDA 510(k) clearance K012544
Creator: U.S. Food and Drug Administration
Published: 2001-11-15

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.. Device class: 2.

Clearance details

Applicant: Vascular Architects, Inc.
Product code: Code JCT
Device class: Class 2
Regulation: 21 CFR 878.3720
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 ↗

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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.