The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Maestro Microcatheter.
| Device ID | K172081 |
| 510k Number | K172081 |
| Device Name: | Maestro Microcatheter |
| Classification | Catheter, Continuous Flush |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Niloufar Samimi |
| Correspondent | Niloufar Samimi Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-10 |
| Decision Date | 2017-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450335298 | K172081 | 000 |
| 10884450307790 | K172081 | 000 |
| 10884450307806 | K172081 | 000 |
| 10884450307813 | K172081 | 000 |
| 10884450307851 | K172081 | 000 |
| 10884450307868 | K172081 | 000 |
| 10884450307899 | K172081 | 000 |
| 10884450307998 | K172081 | 000 |
| 10884450308001 | K172081 | 000 |
| 10884450335212 | K172081 | 000 |
| 10884450335229 | K172081 | 000 |
| 10884450335243 | K172081 | 000 |
| 10884450335250 | K172081 | 000 |
| 10884450335267 | K172081 | 000 |
| 10884450335274 | K172081 | 000 |
| 10884450335281 | K172081 | 000 |
| 00884450335239 | K172081 | 000 |