The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Acist Kodama Intravascular Ultrasound Catheter, Acist Hdi System.
| Device ID | K173063 |
| 510k Number | K173063 |
| Device Name: | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 |
| Contact | Amber R. Luker |
| Correspondent | Amber R. Luker ACIST Medical Systems, Inc. 7905 Fuller Road 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 | 2017-09-29 |
| Decision Date | 2017-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40841716102057 | K173063 | 000 |
| 40841716101982 | K173063 | 000 |
| 40841716101869 | K173063 | 000 |