The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Attain Prevail Left Heart Delivery System Moddel, 6228sys.
| Device ID | K032622 |
| 510k Number | K032622 |
| Device Name: | ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVENUE N. Fridley, MN 55432 -3576 |
| Contact | Lynn Jensen |
| Correspondent | Lynn Jensen MEDTRONIC VASCULAR 7000 CENTRAL AVENUE N. Fridley, MN 55432 -3576 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-26 |
| Decision Date | 2003-09-03 |
| Summary: | summary |