Data / Medical devices / Reprocessed Intravascular Ultrasound Catheter
Reprocessed Intravascular Ultrasound Catheter (OWQ): 13 FDA-registered makers in 3 countries
13 establishments in 3 countries are registered with the FDA to make Reprocessed Intravascular Ultrasound Catheter (product code OWQ, Class 2, 21 CFR 870.1200). 8 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 31 510(k) clearances under this code, the latest on June 29, 2026, and lists 6 recall events (2 Class I). FDA data exported November 3, 2026.
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- Product code
- OWQ
- Device class
- 2
- Regulation
- 870.1200
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Costa Rica | 1 |
| Mexico | 1 |
Makers of Reprocessed Intravascular Ultrasound Catheter
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Abbott Medical Costa Rica Ltda. | El Coyol Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical Mexico, S. de R.L. de C.V. | Santa Rosa Jauregui Queretaro, Mexico | Manufacturer | 0 | 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 June 29, 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.