The following data is part of a premarket notification filed by Qxmedical, Llc with the FDA for Qxmedical Access & Support Catheter.
| Device ID | K123311 |
| 510k Number | K123311 |
| Device Name: | QXMEDICAL ACCESS & SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | QXMEDICAL, LLC 1843 Buerkle Rd White Bear Lake, MN 55110 |
| Contact | Fernando Di Caprio |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-10-25 |
| Decision Date | 2013-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450187750 | K123311 | 000 |
| 20884450168480 | K123311 | 000 |
| 10884450168490 | K123311 | 000 |
| 20884450168503 | K123311 | 000 |
| 20884450168510 | K123311 | 000 |
| 10884450187620 | K123311 | 000 |
| 10884450187637 | K123311 | 000 |
| 20884450187696 | K123311 | 000 |
| 10884450187712 | K123311 | 000 |
| 10884450187736 | K123311 | 000 |
| 20884450187740 | K123311 | 000 |
| 20884450168473 | K123311 | 000 |