The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Attain 6216a-mp Multi-purpose Guide Catheter For Left-heart Delivery.
| Device ID | K024032 |
| 510k Number | K024032 |
| Device Name: | ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis, MN 55432 -3576 |
| Contact | Lynn Jensen |
| Correspondent | Lynn Jensen 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-06 |
| Decision Date | 2002-12-30 |
| Summary: | summary |