Agilis HisPro Steerable Catheter With Electrodes

Catheter, Percutaneous

Abbott (St. Jude Medical)

The following data is part of a premarket notification filed by Abbott (st. Jude Medical) with the FDA for Agilis Hispro Steerable Catheter With Electrodes.

Pre-market Notification Details

Device IDK200721
510k NumberK200721
Device Name:Agilis HisPro Steerable Catheter With Electrodes
ClassificationCatheter, Percutaneous
Applicant Abbott (St. Jude Medical) 15900 Valley View Court Sylmar,  CA  91342
ContactWinnie Yik
CorrespondentWinnie Yik
Abbott (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 Received2020-03-19
Decision Date2020-06-03

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