VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM
FDA 510(k) clearance K012544 · decided 2001-11-15
Clearance details
- K-number
- K012544
- Device name
- VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM
- Applicant
- Vascular Architects, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-07
- Decision date
- 2001-11-15
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- JCT
- Device class
- 2
- Regulation number
- 878.3720
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.