PressureWire X Guidewire

Transducer, Pressure, Catheter Tip

ST. JUDE MEDICAL INC.

The following data is part of a premarket notification filed by St. Jude Medical Inc. with the FDA for Pressurewire X Guidewire.

Pre-market Notification Details

Device IDK161171
510k NumberK161171
Device Name:PressureWire X Guidewire
ClassificationTransducer, Pressure, Catheter Tip
Applicant ST. JUDE MEDICAL INC. 5050 NATHAN LANE NORTH Plymouth,  MN  55442
ContactHuda Yusuf
CorrespondentHuda Yusuf
ST. JUDE MEDICAL INC. 5050 NATHAN LANE NORTH Plymouth,  MN  55442
Product CodeDXO  
Subsequent Product CodeDQX
Subsequent Product CodeDRG
CFR Regulation Number870.2870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-26
Decision Date2016-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15415067025743 K161171 000
15415067025736 K161171 000
05415067025722 K161171 000
15415067025712 K161171 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.