FDA 510(k) Applications Submitted by Michael Sarrasin
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160056 |
01/12/2016 |
t:slim Insulin Delivery System |
Tandem Diabetes Care, Inc. |
| K160482 |
02/22/2016 |
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater |
Tandem Diabetes Care, Inc. |
| K200467 |
02/26/2020 |
Control-IQ Technology |
Tandem Diabetes Care, Inc. |
| DEN190034 |
07/15/2019 |
Control-IQ Technology |
Tandem Diabetes Care, Inc. |
| K162080 |
07/27/2016 |
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater |
Tandem Diabetes Care, Inc. |
| DEN180058 |
10/29/2018 |
t:slim X2 insulin pump with interoperable technology |
Tandem Diabetes Care, Inc. |
| K972958 |
08/11/1997 |
LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS |
LYSONIX, INC. |
| K133892 |
12/20/2013 |
IVUE 500 |
OPTOVUE, INC. |
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