Data / Medical devices / Reprocessed Intravascular Ultrasound Catheter / United States
FDA-registered makers of Reprocessed Intravascular Ultrasound Catheter in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Reprocessed Intravascular Ultrasound Catheter (product code OWQ). 8 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Reprocessed Intravascular Ultrasound Catheter
- Product code
- OWQ
- Country
- United States
Makers of Reprocessed Intravascular Ultrasound Catheter in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Sterilmed, Inc. | Plymouth, MN, United States | Reprocessor, Specification developer | 6 | June 29, 2026 | 0 | 1 | 0 | api.fda.gov |
| Stryker Sustainability Solutions Phoenix | Phoenix, AZ, United States | Reprocessor | 5 | July 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Innovative Health, LLC. | Scottsdale, AZ, United States | Reprocessor | 4 | May 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Stryker Sustainability Solutions | Tempe, AZ, United States | Specification developer | 4 | July 25, 2023 | 0 | 1 | 0 | api.fda.gov |
| Northeast Scientific, Inc. | Waterbury, CT, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 3 | May 12, 2025 | 0 | 1 | 0 | api.fda.gov |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Minnetonka, MN, United States | Manufacturer, Reprocessor, Specification developer | 3 | June 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | June 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| Vein360 | Blue Ash, OH, United States | Reprocessor | 3 | October 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Irvine Biomedical. Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Inc (Maple Grove) | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.