FDA 510(k) Applications Submitted by Jean Chang
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K980631 |
02/18/1998 |
EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA |
EMBOL-X, INC. |
| K140944 |
04/14/2014 |
1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP |
ATHEROMED INC |
| K151145 |
04/29/2015 |
2.4mm X 127 cm Phoenix Atherectomy Deflecting System |
Volcano AtheroMed, Inc. |
| K211518 |
05/17/2021 |
2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System |
Volcano AtheroMed, Inc. |
| K031946 |
06/24/2003 |
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE |
EDWARDS LIFESCIENCES, LLC. |
| K181877 |
07/13/2018 |
Phoenix 2.4mm Atherectomy Plus System |
Volcano AtheroMed Inc. |
| K182972 |
10/26/2018 |
Phoenix Atherectomy System |
Volcano AtheroMed Inc. |
| K143328 |
11/20/2014 |
1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip |
Volcano AtheroMed, Inc. |
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