The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Flexible Luer Lock Adapter With Balance Biosurface, Affinity Flexible Luer Lock Adapter With Carmeda Bioactive.
| Device ID | K123448 |
| 510k Number | K123448 |
| Device Name: | AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Julia A Nelson |
| Correspondent | Julia A Nelson 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 | Yes |
| Date Received | 2012-11-08 |
| Decision Date | 2012-12-13 |
| Summary: | summary |