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 |