TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION

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 Two-lumen Picc With Blue Flextip Catheter And Integral Needle Protection.

Pre-market Notification Details

Device IDK003006
510k NumberK003006
Device Name:TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant ARROW INTL., INC. 2400 BERNVILLE RD. Reading,  PA  19605
ContactThomas D Nickel
CorrespondentThomas D Nickel
ARROW INTL., INC. 2400 BERNVILLE RD. Reading,  PA  19605
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-26
Decision Date2000-10-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30801902095337 K003006 000
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20801902112990 K003006 000
40801902123228 K003006 000
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20801902113379 K003006 000
20801902095330 K003006 000
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40801902113373 K003006 000
30801902093357 K003006 000
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30801902092817 K003006 000
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30801902081477 K003006 000
30801902067457 K003006 000
30801902012938 K003006 000
60801902113384 K003006 000
20801902198796 K003006 000

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