ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
FDA 510(k) clearance K193183 · decided 2020-03-20
Clearance details
- K-number
- K193183
- Device name
- ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
- Applicant
- Acist Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-11-18
- Decision date
- 2020-03-20
- Days to decision
- 123 days
- Clearance type
- Special
- Product code
- OBJ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Cathete recall (Z-1161-2021) | Acist Medical Systems | 2021-03-04 |