A2 DETACHED DUAL PORT SYSTEM

Port & Catheter, Implanted, Subcutaneous, Intravascular

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for A2 Detached Dual Port System.

Pre-market Notification Details

Device IDK955819
510k NumberK955819
Device Name:A2 DETACHED DUAL PORT SYSTEM
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant ARROW INTL., INC. 1600 PROVIDENCE HIGHWAY Walpole,  MA  02081
ContactRichard J Clark
CorrespondentRichard J Clark
ARROW INTL., INC. 1600 PROVIDENCE HIGHWAY Walpole,  MA  02081
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-26
Decision Date1996-03-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.