CPS Aim MediGuide Enabled Inner Catheter, CPS Aim Mediguide Enabled Inner Catheter

Catheter, Percutaneous

St. Jude Medical

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Aim Mediguide Enabled Inner Catheter, Cps Aim Mediguide Enabled Inner Catheter.

Pre-market Notification Details

Device IDK142235
510k NumberK142235
Device Name:CPS Aim MediGuide Enabled Inner Catheter, CPS Aim Mediguide Enabled Inner Catheter
ClassificationCatheter, Percutaneous
Applicant St. Jude Medical 15900 Valley View Court Sylmar,  CA  91342
ContactZachary Price
CorrespondentZachary Price
St. Jude Medical 15900 Valley View Court Sylmar,  CA  91342
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-13
Decision Date2014-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05414734509541 K142235 000
05414734509534 K142235 000
05414734509527 K142235 000
05414734509510 K142235 000
05414734509503 K142235 000

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.