The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Coronary Control Syringe.
| Device ID | K163084 |
| 510k Number | K163084 |
| Device Name: | Merit Coronary Control Syringe |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Cory Marsh |
| Correspondent | Cory Marsh Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-03 |
| Decision Date | 2017-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450055971 | K163084 | 000 |
| 10884450606442 | K163084 | 000 |
| 10884450606480 | K163084 | 000 |
| 10884450606367 | K163084 | 000 |
| 10884450400729 | K163084 | 000 |
| 20884450606531 | K163084 | 000 |
| 10884450606305 | K163084 | 000 |
| 10884450606527 | K163084 | 000 |
| 10884450606466 | K163084 | 000 |
| 10884450606428 | K163084 | 000 |
| 10884450606404 | K163084 | 000 |
| 20884450606630 | K163084 | 000 |
| 20884450606357 | K163084 | 000 |
| 20884450606586 | K163084 | 000 |
| 10884450401054 | K163084 | 000 |
| 10884450606381 | K163084 | 000 |
| 20884450400818 | K163084 | 000 |
| 10884450606619 | K163084 | 000 |
| 20884450606685 | K163084 | 000 |
| 10884450606701 | K163084 | 000 |
| 20884450627307 | K163084 | 000 |
| 20884450400719 | K163084 | 000 |
| 20884450400764 | K163084 | 000 |
| 10884450400965 | K163084 | 000 |
| 10884450400828 | K163084 | 000 |
| 10884450401030 | K163084 | 000 |
| 20884450400702 | K163084 | 000 |
| 10884450400972 | K163084 | 000 |
| 10884450431846 | K163084 | 000 |
| 10884450401016 | K163084 | 000 |
| 10884450401009 | K163084 | 000 |
| 20884450606418 | K163084 | 000 |
| 10884450606329 | K163084 | 000 |
| 10884450606503 | K163084 | 000 |
| 10884450606718 | K163084 | 000 |
| 20884450606562 | K163084 | 000 |
| 20884450401020 | K163084 | 000 |
| 10884450401061 | K163084 | 000 |
| 10884450400699 | K163084 | 000 |
| 10884450606602 | K163084 | 000 |