EXTesia Introducer Sheath Set

Introducer, Catheter

Curatia Medical Co.

The following data is part of a premarket notification filed by Curatia Medical Co. with the FDA for Extesia Introducer Sheath Set.

Pre-market Notification Details

Device IDK220604
510k NumberK220604
Device Name:EXTesia Introducer Sheath Set
ClassificationIntroducer, Catheter
Applicant Curatia Medical Co. 830 Stewart Dr. Sunnyvale,  CA  94085
ContactJessica Chiu
CorrespondentBreanne Butler
Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston,  TX  77043
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-02
Decision Date2022-04-27

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