SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D

Wire, Guide, Catheter

MICRO THERAPEUTICS, INC.

The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Silverspeed Hydrophilic Guidewire (0.014 Diameter, 145cm Length, Support) Silverspeed Hydrophilic Guidewire (0.014 D.

Pre-market Notification Details

Device IDK001454
510k NumberK001454
Device Name:SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
ClassificationWire, Guide, Catheter
Applicant MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine,  CA  92618
ContactMaribelle Aguinaldo
CorrespondentMaribelle Aguinaldo
MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine,  CA  92618
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-09
Decision Date2000-06-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847536006355 K001454 000
00847536004726 K001454 000
00836462003224 K001454 000
00836462003170 K001454 000

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