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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 K220604
Device Name EXTesia Introducer Sheath Set
Curatia Medical Co.
830 Stewart Dr.
Sunnyvale,  CA  94085
Applicant Contact Jessica Chiu
Prime Path Medtech
1321 Upland Dr. Suite 6792
Houston,  TX  77043
Correspondent Contact Breanne Butler
Regulation Number870.1340
Classification Product Code
Date Received03/02/2022
Decision Date 04/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No