The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Acist Hdi System, Acist Kodama Intravascular Ultrasound Catheter.
| Device ID | K193183 |
| 510k Number | K193183 |
| Device Name: | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | ACIST Medical Systems, Inc. 7905 Fuller Rd Eden Prairie, MN 55344 |
| Contact | Angela Johnson |
| Correspondent | Angela Johnson ACIST Medical Systems, Inc. 7905 Fuller Rd Eden Prairie, MN 55344 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-18 |
| Decision Date | 2020-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40841716103511 | K193183 | 000 |
| 30841716103521 | K193183 | 000 |
| 30841716103514 | K193183 | 000 |