FDA 510(k) Applications Submitted by Amber R. Luker
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K172216 | 07/24/2017 | ACIST RXi Mini System | ACIST Medical Systems, Inc. |
| K173063 | 09/29/2017 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | ACIST Medical Systems, Inc. |
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