ARROW PNEUMOTHORAX KIT, AK-01500

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 Pneumothorax Kit, Ak-01500.

Pre-market Notification Details

Device IDK883905
510k NumberK883905
Device Name:ARROW PNEUMOTHORAX KIT, AK-01500
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 - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-15
Decision Date1989-01-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30801902097898 K883905 000
30801902004162 K883905 000
20801902209102 K883905 000
20801902193999 K883905 000

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