The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Connector Components With Balance Biosurface.
| Device ID | K122811 |
| 510k Number | K122811 |
| Device Name: | CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Jacqueline A Hauge |
| Correspondent | Jacqueline A Hauge MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-13 |
| Decision Date | 2012-10-12 |
| Summary: | summary |