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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 K260839
Device Name Protaryx Transseptal Puncture Device (PTX2-001)
Applicant
Protaryx Medical, Inc.
323 W. Camden St.
Suite 600
Baltimore,  MD  21201
Applicant Contact David Mester
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
DRE  
Date Received03/13/2026
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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