Data / Medical devices / Catheter For Crossing Total Occlusions / United States
FDA-registered makers of Catheter For Crossing Total Occlusions in the United States: 16 establishments
16 establishments in the United States are registered with the FDA to make Catheter For Crossing Total Occlusions (product code PDU). 10 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Catheter For Crossing Total Occlusions
- Product code
- PDU
- Country
- United States
Makers of Catheter For Crossing Total Occlusions in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Specification developer | 3 | August 12, 2021 | 0 | 1 | 0 | api.fda.gov |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 3 | May 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| LimFlow Inc. | Irvine, CA, United States | Specification developer | 2 | May 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| AngioSafe | San Jose, CA, United States | Manufacturer | 1 | September 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Reflow Medical, Inc | San Clemente, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | August 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Reflow Medical | Lake Forest, CA, United States | Manufacturer, Repackager or relabeler | 1 | August 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Spectranetics Corp. | Colorado Springs, CO, United States | Complaint file establishment, Manufacturer | 1 | July 11, 2007 | 0 | 0 | 0 | api.fda.gov |
| Volcano Corporation | Rancho Cordova, CA, United States | Manufacturer | 1 | December 2, 2016 | 0 | 1 | 0 | api.fda.gov |
| Volcano Corporation | San Diego, CA, United States | Complaint file establishment, Specification developer | 1 | December 2, 2016 | 0 | 0 | 0 | api.fda.gov |
| ev3, Inc. | Plymouth, MN, United States | Manufacturer | 1 | May 22, 2012 | 0 | 0 | 0 | api.fda.gov |
| Biomerics | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lake Region Medical | Chaska, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medron, LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Laconia, NH, United States | Contract 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.