Arrow Seldinger Arterial Catheterization Device 18 Ga., Arrow Seldinger Arterial Catheterization Device 20 Ga., Arrow Seldinger Arterial Catheterization Device 22 Ga., Arrow Seldinger Arterial Catheterization Device 24 Ga.

Catheter, Percutaneous

Arrow International, Inc. (Subsidiary Of Telelflex Inc.)

The following data is part of a premarket notification filed by Arrow International, Inc. (subsidiary Of Telelflex Inc.) with the FDA for Arrow Seldinger Arterial Catheterization Device 18 Ga., Arrow Seldinger Arterial Catheterization Device 20 Ga., Arrow Seldinger Arterial Catheterization Device 22 Ga., Arrow Seldinger Arterial Catheterization Device 24 Ga..

Pre-market Notification Details

Device IDK171146
510k NumberK171146
Device Name:Arrow Seldinger Arterial Catheterization Device 18 Ga., Arrow Seldinger Arterial Catheterization Device 20 Ga., Arrow Seldinger Arterial Catheterization Device 22 Ga., Arrow Seldinger Arterial Catheterization Device 24 Ga.
ClassificationCatheter, Percutaneous
Applicant Arrow International, Inc. (Subsidiary Of Telelflex Inc.) 2400 Bernville Road Reading,  PA  19605
ContactFallon Young
CorrespondentFallon Young
Arrow International, Inc. (Subsidiary Of Telelflex Inc.) 2400 Bernville Road Reading,  PA  19605
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-19
Decision Date2017-06-23
Summary:summary

NIH GUDID Devices

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