The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Tubing, Conmnectors, And Accessories Wit Balance Biosurface.
| Device ID | K113845 |
| 510k Number | K113845 |
| Device Name: | TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Kevin T Lam |
| Correspondent | Kevin T Lam 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 | 2011-12-28 |
| Decision Date | 2012-01-25 |
| Summary: | summary |