EXCELSIOR 1018 MICROCATHETER

Catheter, Continuous Flush

BOSTON SCIENTIFIC, TARGET

The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Excelsior 1018 Microcatheter.

Pre-market Notification Details

Device IDK994155
510k NumberK994155
Device Name:EXCELSIOR 1018 MICROCATHETER
ClassificationCatheter, Continuous Flush
Applicant BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont,  CA  94538
ContactRoxanne K Baxter
CorrespondentRoxanne K Baxter
BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont,  CA  94538
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-09
Decision Date2000-08-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04546540688125 K994155 000
04546540688118 K994155 000

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