SPECTRA GUIDEWIRE INTRODUCER NEEDLE

Introducer, Catheter

SPECTRA MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Spectra Medical Devices, Inc. with the FDA for Spectra Guidewire Introducer Needle.

Pre-market Notification Details

Device IDK082580
510k NumberK082580
Device Name:SPECTRA GUIDEWIRE INTRODUCER NEEDLE
ClassificationIntroducer, Catheter
Applicant SPECTRA MEDICAL DEVICES, INC. 260-H FORDHAM RD Wilmington,  MA  01887
ContactAgustin Turriza
CorrespondentAgustin Turriza
SPECTRA MEDICAL DEVICES, INC. 260-H FORDHAM RD Wilmington,  MA  01887
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-05
Decision Date2008-12-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20801741086872 K082580 000
M661S010212753 K082580 000
M661S01318275 K082580 000
M661S01321275 K082580 000
30849884004275 K082580 000
30849884004282 K082580 000
30849884004305 K082580 000
38498840011752 K082580 000
38498840011769 K082580 000
20801741045138 K082580 000
M661S013182759 K082580 000

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