The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Attain Lds 6216a Left Heart Delivery System, Attain Access 6218a Left Heart Delivery System, Attain 6216a And 6218a Guid.
| Device ID | K112917 |
| 510k Number | K112917 |
| Device Name: | ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC, INC. 8200 CORAL SEA STREET MS MVS11 Mounds View, MN 55112 |
| Contact | Deborah Kidder |
| Correspondent | Deborah Kidder MEDTRONIC, INC. 8200 CORAL SEA STREET 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 | 2011-10-03 |
| Decision Date | 2011-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994951915 | K112917 | 000 |
| 00613994951908 | K112917 | 000 |
| 00613994951892 | K112917 | 000 |
| 00613994951885 | K112917 | 000 |
| 00613994951878 | K112917 | 000 |
| 00613994951861 | K112917 | 000 |
| 00613994951847 | K112917 | 000 |
| 00613994951830 | K112917 | 000 |