Synchro2 Support Guidewire

Wire, Guide, Catheter

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Synchro2 Support Guidewire.

Pre-market Notification Details

Device IDK190843
510k NumberK190843
Device Name:Synchro2 Support Guidewire
ClassificationWire, Guide, Catheter
Applicant Stryker 47900 Bayside Parkway Fremont,  CA  94538
ContactLorraine Mazzeo
CorrespondentLorraine Mazzeo
Stryker 47900 Bayside Parkway Fremont,  CA  94538
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-01
Decision Date2019-05-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327459661 K190843 000
07613327459654 K190843 000
07613327459647 K190843 000
07613327459630 K190843 000

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