The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Attain Access 6218 Left-heart Delivery System, Model 6218.
| Device ID | K012083 |
| 510k Number | K012083 |
| Device Name: | ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218 |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Karen Reidt |
| Correspondent | Karen Reidt MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-03 |
| Decision Date | 2001-08-28 |
| Summary: | summary |