Data / Medical devices / United States / Surmodics, Inc.
Surmodics, Inc.: FDA-registered device maker in Eden Prairie, MN, United States, 2 510(k) clearances and 1 PMA approval
Surmodics, Inc. is registered with the FDA (registration 3001374820) in Eden Prairie, MN, United States. It lists 3 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated June 16, 2023. 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
- 3001374820
- Address
- 9924 W 74th St, Eden Prairie, MN, United States, 55344
- Owner or operator
- SURMODICS, INC. (9070604)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 29, 2018
- Registered through
- 2026
- Brand names listed
- Sublime Radial Access Guide Sheath, SurVeil Drug-Coated Balloon
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Specification developer | accessdata.fda.gov |
| Drug-Eluting Peripheral Transluminal Angioplasty Catheter | ONU | 3 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Specification developer | 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 18, 2019 | K190644 | Guide Sheath | DYB | Substantially Equivalent | Surmodics,Inc. | accessdata.fda.gov |
| January 12, 2018 | K173560 | Microcatheter | DQY | Substantially Equivalent | Surmodics,Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 16, 2023 | P210025 | SurVeil Drug-Coated Balloon | ONU | 6 | June 6, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous
- All makers of Introducer, Catheter
- All makers of Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Updated June 6, 2025. 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.