The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Benelli Access Device.
| Device ID | K111334 |
| 510k Number | K111334 |
| Device Name: | BENELLI ACCESS DEVICE |
| Classification | Catheter, Percutaneous |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Jennifer Ruether |
| Correspondent | Jennifer Ruether VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-12 |
| Decision Date | 2011-08-01 |
| Summary: | summary |