The following data is part of a premarket notification filed by Qxmedical, Llc with the FDA for Q50 Plus Stent Graft Balloon Catheter.
| Device ID | K120381 |
| 510k Number | K120381 |
| Device Name: | Q50 PLUS STENT GRAFT BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | QXMEDICAL, LLC 1747 SUMMIT AVENUE St. Paul, MN 55105 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-02-07 |
| Decision Date | 2012-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853892004447 | K120381 | 000 |
| 00853892004089 | K120381 | 000 |
| 00853892004072 | K120381 | 000 |
| 00853892004065 | K120381 | 000 |
| 00853892004010 | K120381 | 000 |
| 00853892004003 | K120381 | 000 |