Heraeus Peripheral Guidewire

Wire, Guide, Catheter

Heraeus Medical Components, LLC

The following data is part of a premarket notification filed by Heraeus Medical Components, Llc with the FDA for Heraeus Peripheral Guidewire.

Pre-market Notification Details

Device IDK191502
510k NumberK191502
Device Name:Heraeus Peripheral Guidewire
ClassificationWire, Guide, Catheter
Applicant Heraeus Medical Components, LLC 2605 Fernbrook Lane North, Suite J Plymouth,  MN  55447
ContactChelsea Pioske
CorrespondentChelsea Pioske
Heraeus Medical Components, LLC 2605 Fernbrook Lane North, Suite J Plymouth,  MN  55447
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-06
Decision Date2019-11-26
Summary:summary

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