The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Intelliflator(tm) & Merit Monitor(tm).
| Device ID | K884913 |
| 510k Number | K884913 |
| Device Name: | MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107 |
| Contact | Fred Lampropoulos |
| Correspondent | Fred Lampropoulos MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-28 |
| Decision Date | 1989-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450298002 | K884913 | 000 |
| 10884450297992 | K884913 | 000 |
| 10884450297985 | K884913 | 000 |
| 10884450028039 | K884913 | 000 |
| 10884450024598 | K884913 | 000 |
| 10884450021467 | K884913 | 000 |
| 10884450006594 | K884913 | 000 |