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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K221914
Device Name Catapult Guide Sheath
Applicant
Contract Medical International, GmbH
Lauensteiner Strasse 37
Dresden,  DE 01277
Applicant Contact Juliana Vaz Nuernberger
Correspondent
Contract Medical International S.R.O.
Vazni 848
Hradec Kralove,  CZ 50011
Correspondent Contact Jan Kubicek
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
DRE  
Date Received06/30/2022
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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