Submission Details
| 510(k) Number | K191175 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 01, 2019 |
| Decision Date | June 27, 2019 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
Jun 2019
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K191175 is an FDA 510(k) clearance for the ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on June 27, 2019, 57 days after receiving the submission on May 1, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| Product Code | OBJ — Catheter, Ultrasound, Intravascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| Definition | For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology. |
Manufacturer
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