The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Attain Lds 6216 Left-heart Delivery System.
| Device ID | K012130 |
| 510k Number | K012130 |
| Device Name: | ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis, MN 55432 -3576 |
| Contact | Karen Reidt |
| Correspondent | Karen Reidt MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis, MN 55432 -3576 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-09 |
| Decision Date | 2001-08-28 |
| Summary: | summary |