Data / Medical devices / Catheter, Septostomy / United States
FDA-registered makers of Catheter, Septostomy in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Catheter, Septostomy (product code DXF). 10 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Catheter, Septostomy
- Product code
- DXF
- Country
- United States
Makers of Catheter, Septostomy in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Atraverse Medical | Solana Beach, CA, United States | Complaint file establishment, Specification developer | 3 | February 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Atraverse Medical | Cardiff by the Sea, CA, United States | Complaint file establishment, Specification developer | 3 | February 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 3 | November 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| CIRCA Scientific, Inc. | Englewood, CO, United States | Specification developer | 3 | May 1, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 2 | June 17, 2015 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | July 28, 1980 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences LLC | Irvine, CA, United States | Manufacturer | 1 | August 22, 2022 | 0 | 1 | 1 | api.fda.gov |
| Electrowire Corporation Dba Electrowire Medical | Lexington, SC, United States | Manufacturer | 1 | June 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Numed, Inc. | Hopkinton, NY, United States | Manufacturer | 1 | July 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Pressure Products Medical Device Manufacturing LLC | Morton, PA, United States | Manufacturer | 1 | March 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Lake Region Medical | Chaska, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pathway Medtech, LLC. | Santee, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, 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.