Boosting Catheter

Catheter, Percutaneous

QXMEDICAL, LLC

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

Pre-market Notification Details

Device IDK160561
510k NumberK160561
Device Name:Boosting Catheter
ClassificationCatheter, Percutaneous
Applicant QXMEDICAL, LLC 2820 PATTON ROAD Roseville,  MN  55113
ContactFernando Di Caprio
CorrespondentFernando Di Caprio
QXMEDICAL, LLC 2820 PATTON ROAD Roseville,  MN  55113
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-29
Decision Date2016-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853892004058 K160561 000
00853892004041 K160561 000
00853892004034 K160561 000
00853892004027 K160561 000

Trademark Results [Boosting Catheter]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BOOSTING CATHETER
BOOSTING CATHETER
86839516 not registered Dead/Abandoned
QxMedical, LLC
2015-12-04

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