FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
K Number: K060239
·
Decision Mar 22, 2006
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
58
Applicant Total
12
Review Days
50
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Basic Information
- Device Name
- ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
- K Number
- K060239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alveolus, Inc.
- Date Received
- January 31, 2006
- Decision Date
- March 22, 2006
- Product Code
- ESW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ESW | Prosthesis, Esophageal | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Alveolus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K083625 | AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Mar 11, 2009 | Unknown |
| K082284 | AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM | Nov 20, 2008 | Unknown |
| K080838 | ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | Apr 24, 2008 | Substantially Equivalent |
| K072720 | ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM | Apr 11, 2008 | Unknown |
| K071604 | ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Sep 19, 2007 | Unknown |
| K062511 | AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX | Jan 31, 2007 | Unknown |
| K051621 | ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | Jul 11, 2005 | Substantially Equivalent |
| K033990 | ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM | May 12, 2004 | Substantially Equivalent |
| K033053 | ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Feb 25, 2004 | Substantially Equivalent |
| K032744 | ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Nov 13, 2003 | Substantially Equivalent |