Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825) +3 more— 510(k) K254149
Substantially EquivalentSterilmed, Inc.
FDA 510(k) clearance K254149 for Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825) +3 more, Substantially Equivalent on 2026-06-29. Applicant: Sterilmed, Inc.. Device class: 2.
Summary
Sterilmed's clearance covers four reprocessed 9F x 90 cm ultrasound catheters, filed under OWQ, reprocessed intravascular ultrasound catheters. The model numbers are R11510825 and R11657484 for AcuNav CRYSTAL (Siemens and GE systems) and R11510826 and R11657485 for SOUNDSTAR CRYSTAL (Siemens and GE systems).
Class II, 21 CFR 870.1200. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Sterilmed filed from Plymouth, Minnesota. The decision came 189 calendar days after FDA received it (December 22, 2025 to June 29, 2026).
Clearance details
- Device name as filed
- 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.
- Product code
- Product code OWQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code OWQ
view all- K250545 — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
- K250592 — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
- K243101 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ) +1 more
- K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936) +1 more
- K232130 — Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
More clearances from Sterilmed, Inc.
view all- K240826 — Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
- K190478 — Reprocessed ViewFlex Xtra ICE Catheter
- K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
- K161700 — SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
Data sourced from openFDA. This site is unofficial and independent of the FDA.