The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Arcadia Balloon Catheter.
| Device ID | K191596 |
| 510k Number | K191596 |
| Device Name: | Arcadia Balloon Catheter |
| Classification | Arthroscope |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Shamsa Karimi |
| Correspondent | Shamsa Karimi Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | HRX |
| Subsequent Product Code | HXG |
| Subsequent Product Code | NDN |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-17 |
| Decision Date | 2019-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450447229 | K191596 | 000 |
| 10884450490881 | K191596 | 000 |
| 00884450447116 | K191596 | 000 |
| 10884450490898 | K191596 | 000 |
| 10884450490874 | K191596 | 000 |
| 00884450447291 | K191596 | 000 |
| 10884450490867 | K191596 | 000 |
| 00884450447208 | K191596 | 000 |
| 00884450490846 | K191596 | 000 |
| 00884450490839 | K191596 | 000 |
| 00884450490914 | K191596 | 000 |
| 00884450447178 | K191596 | 000 |
| 10884450447137 | K191596 | 000 |
| 00884450462539 | K191596 | 000 |
| 10884450447168 | K191596 | 000 |
| 10884450447106 | K191596 | 000 |
| 10884450447373 | K191596 | 000 |
| 10884450447250 | K191596 | 000 |
| 10884450447342 | K191596 | 000 |
| 10884450447281 | K191596 | 000 |
| 00884450447352 | K191596 | 000 |
| 00884450447239 | K191596 | 000 |
| 10884450447199 | K191596 | 000 |
| 10884450447311 | K191596 | 000 |
| 00884450547557 | K191596 | 000 |