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 |