FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOLOGIX AFX INTRODUCER SYSTEM
K Number: K111747
·
Decision Jul 12, 2011
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
5
Review Days
20
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Basic Information
- Device Name
- ENDOLOGIX AFX INTRODUCER SYSTEM
- K Number
- K111747
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endologix, Inc.
- Date Received
- June 22, 2011
- Decision Date
- July 12, 2011
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Endologix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120212 | AFX INTRODUCER SYSTEM | Feb 9, 2012 | Substantially Equivalent |
| K110090 | AFX INTRODUCER SYSTEM | May 26, 2011 | Substantially Equivalent |
| K080360 | ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER | Apr 8, 2008 | Substantially Equivalent |
| K991601 | DUAL LUMEN CATHETER, MODEL DL-35-90 | Oct 28, 1999 | Substantially Equivalent |