The following data is part of a premarket notification filed by Acist Medical Systems, Inc. with the FDA for Acistcvi® Contrast Delivery System.
| Device ID | K171646 |
| 510k Number | K171646 |
| Device Name: | ACISTCVi® Contrast Delivery System |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 |
| Contact | Melissa Sommerfeld |
| Correspondent | Melissa Sommerfeld ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-06-05 |
| Decision Date | 2018-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40841716101883 | K171646 | 000 |
| 40841716101876 | K171646 | 000 |
| 30841716102036 | K171646 | 000 |
| 30841716101947 | K171646 | 000 |
| 10841716101684 | K171646 | 000 |
| 30841716101978 | K171646 | 000 |
| 30841716101565 | K171646 | 000 |
| 30841716102005 | K171646 | 000 |
| 30841716101992 | K171646 | 000 |