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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K252792
Device Name PM2™ System with ECGuide™ Connector
Applicant
Piccolo Medical, Inc.
218 Mississippi St.
San Francisco,  CA  94107
Applicant Contact Augustus Shanahan
Correspondent
RQM+
2790 Mosside Blvd. #800
Monroeville,  PA  15146
Correspondent Contact Alexia Haralambous
Regulation Number880.5970
Classification Product Code
LJS  
Subsequent Product Codes
DRX   DSA  
Date Received09/02/2025
Decision Date 11/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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