The following data is part of a premarket notification filed by Qxmedical, Llc with the FDA for Support Catheter.
| Device ID | K200317 |
| 510k Number | K200317 |
| Device Name: | Support Catheter |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-07 |
| Decision Date | 2020-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15051684029612 | K200317 | 000 |
| 15051684029476 | K200317 | 000 |
| 15051684029483 | K200317 | 000 |
| 15051684029490 | K200317 | 000 |
| 15051684029506 | K200317 | 000 |
| 15051684029513 | K200317 | 000 |
| 15051684029520 | K200317 | 000 |
| 15051684029537 | K200317 | 000 |
| 15051684029544 | K200317 | 000 |
| 15051684029551 | K200317 | 000 |
| 15051684029575 | K200317 | 000 |
| 15051684029582 | K200317 | 000 |
| 15051684029599 | K200317 | 000 |
| 15051684029605 | K200317 | 000 |
| H787181801 | K200317 | 000 |