The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Attain Command 6250 Left Heart Delivery Systems And Guide Catheters For Left Heart Delivery.
| Device ID | K090659 |
| 510k Number | K090659 |
| Device Name: | ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA ST NE MS:MVS11 Mounds View, MN 55112 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund MEDTRONIC INC. 8200 CORAL SEA ST NE MS:MVS11 Mounds View, MN 55112 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-12 |
| Decision Date | 2009-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994334954 | K090659 | 000 |
| 00613994334848 | K090659 | 000 |
| 00613994334855 | K090659 | 000 |
| 00613994334862 | K090659 | 000 |
| 00613994334879 | K090659 | 000 |
| 00613994334886 | K090659 | 000 |
| 00613994334893 | K090659 | 000 |
| 00613994334909 | K090659 | 000 |
| 00613994334916 | K090659 | 000 |
| 00613994334923 | K090659 | 000 |
| 00613994334930 | K090659 | 000 |
| 00613994334947 | K090659 | 000 |
| 00613994334831 | K090659 | 000 |