FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFX INTRODUCER SYSTEM
K Number: K120212
·
Decision Feb 9, 2012
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
5
Review Days
16
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Basic Information
- Device Name
- AFX INTRODUCER SYSTEM
- K Number
- K120212
- 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
- January 24, 2012
- Decision Date
- February 9, 2012
- 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 | ||
|---|---|---|---|
| K111747 | ENDOLOGIX AFX INTRODUCER SYSTEM | Jul 12, 2011 | 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 |