Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)
FDA 510(k) K243101 · Surgical Instrument Service and Savings, Inc.
510(k) numberK243101
Submission
- Device name
- Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)
- Applicant
- Surgical Instrument Service and Savings, Inc.
Redmond, OR, US - Received
- September 30, 2024
- Decision date
- March 10, 2025
- 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 |
|---|---|---|---|
| K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…OWQ · Traditional | Sterilmed, Inc. | 06/29/2026SE |
| 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 |
| 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 |
|---|---|---|
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerPNE · Traditional | 12/19/2025SE |
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable…NLH · Traditional | 11/26/2025SE |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable…NLH · Traditional | 07/11/2025SE |
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…OWQ · Traditional | 06/05/2025SE |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterNLH · Traditional | 11/29/2024SE |
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter…NLH · Traditional | 09/14/2024SE |
| K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens…OWQ · Traditional | 09/10/2024SE |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)NLH · Traditional | 06/07/2024SE |
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)NUJ · Traditional | 04/29/2024SE |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterNLH · Traditional | 05/31/2023SE |
Questions and answers
When was Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) cleared by the FDA?
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) (K243101) received a 510(k) decision of Substantially Equivalent on March 10, 2025, 161 days after the submission was received.
What is the product code of K243101?
The FDA product code is OWQ – Reprocessed Intravascular Ultrasound Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1200.