FDA 510(k) Applications Submitted by Loucinda Bjorklund
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| DEN220012 |
02/08/2022 |
Tornier Pyrocarbon Humeral Head |
Tornier SAS |
| K140327 |
02/10/2014 |
ULTIMUM EV HEMOSTASIS INTRODUCER |
ST. JUDE MEDICAL |
| K160975 |
04/07/2016 |
Aequalis PerFORM+ Shoulder System |
TORNIER, INC. |
| K101239 |
05/03/2010 |
VIEWFLEX PLUS ICE CATHETER |
ST. JUDE MEDICAL |
| K091345 |
05/06/2009 |
GOPHER GOLD CATHETER, MODEL 5620 |
VASCULAR SOLUTIONS, INC. |
| K121381 |
05/08/2012 |
VIEWFLEX XTRA ICE CATHETER |
ST. JUDE MEDICAL |
| K091551 |
05/27/2009 |
VARI-LASE PLATINUM BRIGHT TIP LASER FIBER |
VASCULAR SOLUTIONS, INC. |
| K091750 |
06/16/2009 |
GUIDELINER CATHETER, MODELS 5571, 5572, 5573 |
VASCULAR SOLUTIONS, INC. |
| K092563 |
08/20/2009 |
GATOR CLIPSEAL PLUG |
VASCULAR SOLUTIONS, INC. |
| K143552 |
12/15/2014 |
Simpliciti Shoulder System |
TORNIER, INC. |
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