Catapult Guide Sheath

Introducer, Catheter

Contract Medical International GmbH

The following data is part of a premarket notification filed by Contract Medical International Gmbh with the FDA for Catapult Guide Sheath.

Pre-market Notification Details

Device IDK221914
510k NumberK221914
Device Name:Catapult Guide Sheath
ClassificationIntroducer, Catheter
Applicant Contract Medical International GmbH Lauensteiner Strasse 37 Dresden,  DE 01277
ContactJuliana Vaz Nuernberger
CorrespondentJan Kubicek
Contract Medical International S.r.o. Vazni 848 Hradec Kralove,  CZ 50011
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-30
Decision Date2022-07-29

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