FDA 510(k) Applications Submitted by Theresa Brandner
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K161202 |
04/28/2016 |
C2 Cryoballoon Ablation System |
C2 THERAPEUTICS, INC. |
| K182487 |
09/11/2018 |
CerusEndo Microcatheter |
Cerus Endovascular, Inc. |
| K150083 |
01/15/2015 |
Sidecar External Working Channel |
C2 THERAPEUTICS |
| K070970 |
04/06/2007 |
NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F |
PENUMBRA, INC. |
| K160994 |
04/08/2016 |
C2 CryoBalloon Focal Pear Catheter |
C2 THERAPEUTICS, INC. |
| K151054 |
04/20/2015 |
Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System |
C2 Therapeutics, Inc. |
| K152140 |
08/03/2015 |
Boa Endoscopic Valve |
C2 THERAPEUTICS, INC. |
| K082290 |
08/11/2008 |
NEURON DELIVERY CATHETER 070 |
PENUMBRA, INC. |
| K152329 |
08/18/2015 |
Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System |
C2 Therapeutics, Inc. |
| K072718 |
09/25/2007 |
PENUMBRA SYSTEM |
PENUMBRA, INC. |
| K083125 |
10/22/2008 |
NEURON SELECT CATHETER SIZE 070 |
PENUMBRA, INC. |
| K153541 |
12/10/2015 |
Coldplay CryoBalloon« Ablation System |
C2 THERAPEUTICS, INC. |
| K053491 |
12/15/2005 |
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F |
PENUMBRA, INC. |
| K113697 |
12/16/2011 |
EIGR SURGICAL ILLUMINATION SYSTEM |
INVUITY, INC. |
| K163684 |
12/28/2016 |
C2 CryoBalloon Ablation System |
C2 Therapeutics, Inc. |
| K051758 |
06/29/2005 |
PENUMBRA ASPIRATION PUMP, MODEL 115V |
PENUMBRA, INC. |
| K955534 |
12/04/1995 |
SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) |
INTERNATIONAL INNOVATIONS, INC. |
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