The following data is part of a premarket notification filed by Endologix, Inc. with the FDA for Afx Introducer System.
| Device ID | K110090 |
| 510k Number | K110090 |
| Device Name: | AFX INTRODUCER SYSTEM |
| Classification | Introducer, Catheter |
| Applicant | ENDOLOGIX, INC. 11 STUDEBAKER Irvine, CA 92618 |
| Contact | Janet M Fauls |
| Correspondent | Janet M Fauls ENDOLOGIX, INC. 11 STUDEBAKER Irvine, CA 92618 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-12 |
| Decision Date | 2011-05-26 |
| Summary: | summary |