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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K260289
Device Name Perfect-O Ostial Positioning Catheter
Applicant
Balosmark, Inc.
2348 Sheffield Dr.
Kalamazoo,  MI  49008
Applicant Contact Tim Fischell
Correspondent
Gateway Medical Consulting Services, LLC
5 Scotch Pine Ln.
St. Paul,  MN  55127
Correspondent Contact Nancy Frame
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/29/2026
Decision Date 06/05/2026
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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