SHEATH ADAPTER, MODEL SA-09847

Introducer, Catheter

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Sheath Adapter, Model Sa-09847.

Pre-market Notification Details

Device IDK021723
510k NumberK021723
Device Name:SHEATH ADAPTER, MODEL SA-09847
ClassificationIntroducer, Catheter
Applicant ARROW INTL., INC. 2400 BERNVILLE RD. Reading,  PA  19605
ContactBrandon Epting
CorrespondentBrandon Epting
ARROW INTL., INC. 2400 BERNVILLE RD. Reading,  PA  19605
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-24
Decision Date2002-08-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30801902101571 K021723 000
30801902026140 K021723 000

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