Arrow Epidural Catheter Kit

Anesthesia Conduction Kit

Teleflex Medical, Inc.

The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Arrow Epidural Catheter Kit.

Pre-market Notification Details

Device IDK143581
510k NumberK143581
Device Name:Arrow Epidural Catheter Kit
ClassificationAnesthesia Conduction Kit
Applicant Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville,  NC  27560
ContactAngela Bouse
CorrespondentAngela Bouse
Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville,  NC  27560
Product CodeCAZ  
CFR Regulation Number868.5140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-18
Decision Date2015-06-26
Summary:summary

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