The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Miser Contrast Management System.
| Device ID | K083576 |
| 510k Number | K083576 |
| Device Name: | MISER CONTRAST MANAGEMENT SYSTEM |
| Classification | Set, Administration, Intravascular |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Stephanie Erskine |
| Correspondent | Stephanie Erskine MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-03 |
| Decision Date | 2008-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450116989 | K083576 | 000 |
| 10884450109127 | K083576 | 000 |
| 10884450099893 | K083576 | 000 |
| 10884450014223 | K083576 | 000 |
| 10884450014216 | K083576 | 000 |