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)
FDA 510(k) K254149 · Sterilmed, Inc.
510(k) numberK254149
Submission
- 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.
Plymouth, MN, US - Received
- December 22, 2025
- Decision date
- June 29, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWQ – Reprocessed Intravascular Ultrasound Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Other 510(k)s with product code OWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…OWQ · Traditional | Surgical Instrument Service and Savings, Inc. | 06/05/2025SE |
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)OWQ · Traditional | Northeast Scientific, Inc. | 05/12/2025SE |
| K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens…OWQ · Traditional | Surgical Instrument Service and Savings, Inc. | 03/10/2025SE |
| K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens…OWQ · Traditional | Surgical Instrument Service and Savings, Inc. | 09/10/2024SE |
| K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterOWQ · Traditional | Surgical Instrument Services and Savings, Inc. | 12/15/2023SE |
| K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…OWQ · Traditional | Vein 360, LLC | 10/24/2023SE |
| K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterOWQ · Traditional | Vein 360, LLC | 08/25/2023SE |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031)OWQ · Special | Stryker Sustainability Solutions | 07/25/2023SE |
| K231588 | ViewFlex Eco Reprocessed ICE CatheterOWQ · Special | Abbott Medical | 06/30/2023SE |
| K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterOWQ · Traditional | Vein 360, LLC | 06/06/2023SE |
More from Vein 360, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional | 10/11/2024SE |
| K190478 | Reprocessed ViewFlex Xtra ICE CatheterOWQ · Traditional | 11/14/2019SE |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | 08/15/2019SE |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional | 04/15/2019SE |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…OWQ · Traditional | 11/21/2016SE |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…NUJ · Traditional | 09/20/2016SE |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH · Traditional | 06/23/2016SE |
| K152090 | Reprocessed Steerable IntroducerPNE · Traditional | 03/23/2016SE |
| K152134 | Reprocessed Vessel SealerNUJ · Traditional | 01/15/2016SE |
| K150357 | Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional | 08/27/2015SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K254149) received a 510(k) decision of Substantially Equivalent on June 29, 2026, 189 days after the submission was received.
What is the product code of K254149?
The FDA product code is OWQ – Reprocessed Intravascular Ultrasound Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1200.