The following data is part of a premarket notification filed by Qxmedical, Llc with the FDA for Occlusion Balloon Catheter.
| Device ID | K183679 |
| 510k Number | K183679 |
| Device Name: | Occlusion Balloon Catheter |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | QXMedical, LLC 2820 Patton Road Roseville, MN 55113 |
| Contact | Fernando Di Caprio |
| Correspondent | Fernando Di Caprio QXMedical, LLC 2820 Patton Road Roseville, MN 55113 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-28 |
| Decision Date | 2019-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853892004126 | K183679 | 000 |
| 00853892004119 | K183679 | 000 |