510(k) K193183 ยท OBJ Catheter, Ultrasound, Intravascular
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
| Applicant | Acist Medical Systems, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Mar 20, 2020 |
| Received | Nov 18, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193183
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2021 | Acist Medical Systems ACIST Kodama Intravascular Ultrasound Catheter
The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examina Terminated |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.