The following data is part of a premarket notification filed by Qxmedical, Llc with the FDA for Boosting Catheter.
| Device ID | K160561 |
| 510k Number | K160561 |
| Device Name: | Boosting 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 | 2016-02-29 |
| Decision Date | 2016-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853892004058 | K160561 | 000 |
| 00853892004041 | K160561 | 000 |
| 00853892004034 | K160561 | 000 |
| 00853892004027 | K160561 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BOOSTING CATHETER 86839516 not registered Dead/Abandoned |
QxMedical, LLC 2015-12-04 |