The following data is part of a premarket notification filed by Abbott Vascular-vascular Solutions with the FDA for Absolute Pro .035 Self-expanding Stent System.
| Device ID | K072708 |
| 510k Number | K072708 |
| Device Name: | ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ABBOTT VASCULAR-VASCULAR SOLUTIONS 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | Michelle Grossman |
| Correspondent | Michelle Grossman ABBOTT VASCULAR-VASCULAR SOLUTIONS 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-25 |
| Decision Date | 2008-08-18 |
| Summary: | summary |