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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reprocessed Intravascular Ultrasound Catheter
510(k) Number K254149
Device Name Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)
Applicant
Sterilmed, Inc.
5010 Cheshire Pkwy. N.
Suite 2
Plymouth,  MN  55446
Applicant Contact Rachel Poltilove
Correspondent
Sterilmed, Inc.
5010 Cheshire Pkwy. N.
Suite 2
Plymouth,  MN  55446
Correspondent Contact Rachel Poltilove
Regulation Number870.1200
Classification Product Code
OWQ  
Date Received12/22/2025
Decision Date 06/29/2026
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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