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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K252674
Device Name Solo Pace Fusion System (SOLOFUSE1)
Applicant
Solo Pace, Inc.
1201 Sutter St.
Suite 303
San Francisco,  CA  94109
Applicant Contact Matt Olson
Correspondent
Gateway Medical Consulting Services, LLC
5 Scotch Pine Ln.
St. Paul,  MN  55127
Correspondent Contact Nancy Frame
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
LDF  
Date Received08/25/2025
Decision Date 01/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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