ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT

Catheter And Tip, Suction

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow-clarke(tm) Pleura-seal(tm) Thoracentesis Kit.

Pre-market Notification Details

Device IDK870572
510k NumberK870572
Device Name:ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT
ClassificationCatheter And Tip, Suction
Applicant ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading,  PA  19610
ContactThomas D Nickel
CorrespondentThomas D Nickel
ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading,  PA  19610
Product CodeJOL  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-10
Decision Date1987-05-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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30801902002700 K870572 000
30801902002694 K870572 000
50801902120132 K870572 000
70801902004795 K870572 000
20801902197973 K870572 000

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