SavvyWire

Wire, Guide, Catheter

Opsens Inc.

The following data is part of a premarket notification filed by Opsens Inc. with the FDA for Savvywire.

Pre-market Notification Details

Device IDK213854
510k NumberK213854
Device Name:SavvyWire
ClassificationWire, Guide, Catheter
Applicant Opsens Inc. 750 Boulevard Du Parc Technologique Québec,  CA G1P 4S3
ContactMarc Chaunet
CorrespondentChristina Henza
Ultra Lifescience Solutions, Inc. 2811 Milton Ave, #409 Janesville,  WI  53545
Product CodeDQX  
Subsequent Product CodeDXO
Subsequent Product CodeLDF
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-10
Decision Date2022-09-14

Trademark Results [SavvyWire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAVVYWIRE
SAVVYWIRE
90030655 not registered Live/Pending
OPSENS INC.
2020-07-01

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