Data / Medical devices / United States / Protaryx Medical, LLC
Protaryx Medical, LLC: FDA-registered device maker in Baltimore, MD, United States, 1 510(k) clearance
Protaryx Medical, LLC is registered with the FDA (registration 3046772394) in Baltimore, MD, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3046772394
- Address
- 323 W Camden St Ste 600, Baltimore, MD, United States, 21201
- Owner or operator
- Protaryx Medical, LLC (10096153)
- Roles
- Manufacturer
- First device listed
- July 10, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2026 | K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | DYB | Substantially Equivalent | Protaryx Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 10, 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.