STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES

Wire, Guide, Catheter

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Stainless Steel Gen Pur Interventional Guide Wires.

Pre-market Notification Details

Device IDK914531
510k NumberK914531
Device Name:STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
ClassificationWire, Guide, Catheter
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 CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-11
Decision Date1992-02-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30801902101540 K914531 000
20801902218968 K914531 000
40801902122542 K914531 000
30801902007330 K914531 000
40801902122467 K914531 000
40801902122474 K914531 000
40801902122498 K914531 000
30801902122538 K914531 000
40801902128902 K914531 000
30801902003288 K914531 000
30801902003295 K914531 000
20801902003304 K914531 000
40801902122450 K914531 000
30801902003226 K914531 000
30801902003264 K914531 000
30801902007316 K914531 000
20801902220831 K914531 000

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