Reprocessed ViewFlex Xtra ICE Catheter (D087031)
FDA 510(k) K231621 · Stryker Sustainability Solutions
510(k) numberK231621
Submission
- Device name
- Reprocessed ViewFlex Xtra ICE Catheter (D087031)
- Applicant
- Stryker Sustainability Solutions
Tempe, AZ, US - Received
- June 2, 2023
- Decision date
- July 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
| 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 |
| 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 |
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| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | 06/18/2026SE |
| K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears…NLQ · Traditional | 08/14/2025SE |
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| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…NLQ · Special | 07/03/2024SE |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…NLQ · Traditional | 02/20/2024SE |
| K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019GEI · Special | 03/28/2023SE |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Special | 03/28/2023SE |
| K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…NLF · Traditional | 12/04/2022SE |
| K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)GEI · Traditional | 05/25/2022SE |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Traditional | 05/13/2022SE |
Questions and answers
When was Reprocessed ViewFlex Xtra ICE Catheter (D087031) cleared by the FDA?
Reprocessed ViewFlex Xtra ICE Catheter (D087031) (K231621) received a 510(k) decision of Substantially Equivalent on July 25, 2023, 53 days after the submission was received.
What is the product code of K231621?
The FDA product code is OWQ – Reprocessed Intravascular Ultrasound Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1200.