QXMEDICAL ACCESS & SUPPORT CATHETER

Catheter, Percutaneous

QXMEDICAL, LLC

The following data is part of a premarket notification filed by Qxmedical, Llc with the FDA for Qxmedical Access & Support Catheter.

Pre-market Notification Details

Device IDK123311
510k NumberK123311
Device Name:QXMEDICAL ACCESS & SUPPORT CATHETER
ClassificationCatheter, Percutaneous
Applicant QXMEDICAL, LLC 1843 Buerkle Rd White Bear Lake,  MN  55110
ContactFernando Di Caprio
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-10-25
Decision Date2013-01-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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