Arrow Pressure Injectable Midline Catheter

Midline Catheter

Arrow International LLC Subsidiary Of Teleflex Incorporated

The following data is part of a premarket notification filed by Arrow International Llc Subsidiary Of Teleflex Incorporated with the FDA for Arrow Pressure Injectable Midline Catheter.

Pre-market Notification Details

Device IDK213855
510k NumberK213855
Device Name:Arrow Pressure Injectable Midline Catheter
ClassificationMidline Catheter
Applicant Arrow International LLC Subsidiary Of Teleflex Incorporated 3015 Carrington Mill Blvd Morrisville,  NC  27560
ContactKim Pennington
CorrespondentKim Pennington
Arrow International LLC Subsidiary Of Teleflex Incorporated 3015 Carrington Mill Blvd Morrisville,  NC  27560
Product CodePND  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-10
Decision Date2022-09-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20801902216834 K213855 000
20801902216827 K213855 000
20801902218852 K213855 000

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