The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Tri-optic Measurement Cell; With Balance Biosurface, With Carmeda Bioactive Surface, With Trillium Biosurface, With 6.
| Device ID | K133157 |
| 510k Number | K133157 |
| Device Name: | TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Jessica Sixberry |
| Correspondent | Jessica Sixberry MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-10-23 |
| Summary: | summary |