ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION

Wire, Guide, Catheter

ECHOCATH, INC.

The following data is part of a premarket notification filed by Echocath, Inc. with the FDA for Echomark Guidewire With Ultrasonic Localization.

Pre-market Notification Details

Device IDK922787
510k NumberK922787
Device Name:ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION
ClassificationWire, Guide, Catheter
Applicant ECHOCATH, INC. P.O. BOX 7224 Princeton,  NJ  08543 -7224
ContactDe Bernardis
CorrespondentDe Bernardis
ECHOCATH, INC. P.O. BOX 7224 Princeton,  NJ  08543 -7224
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-09
Decision Date1993-01-06

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