Data / Medical devices / United States / Surmodics, Inc.
Surmodics, Inc.: FDA-registered device maker in Eden Prairie, MN, United States, 8 510(k) clearances and 1 PMA approval
Surmodics, Inc. is registered with the FDA (registration 3014687026) in Eden Prairie, MN, United States. It lists 6 device types. The FDA files 8 510(k) clearances and 1 PMA approval under its listings, the newest dated September 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014687026
- Address
- 7905 Golden Triangle Drive Suite 190, Eden Prairie, MN, United States, 55344
- Owner or operator
- SURMODICS, INC. (9070604)
- Roles
- Complaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 29, 2018
- Registered through
- 2026
- Brand names listed
- Pounce Sheath, Pounce LP Thrombectomy, Pounce Sheath, Pounce Thrombectomy, Pounce Venous Thrombectomy System, Pounce XL Thrombectomy, SublimeTM Radial Access 014 RX PTA Dilatation Catheter, SublimeTM Radial Access 018 RX Dilatation Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Complaint file establishment | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Complaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Drug-Eluting Peripheral Transluminal Angioplasty Catheter | ONU | 3 | Complaint file establishment | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 2 | Complaint file establishment, Contract manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 24, 2025 | K252227 | Pounce(TM) Sheath | DYB | Substantially Equivalent | Surmodics,Inc. | accessdata.fda.gov |
| September 7, 2023 | K231828 | Pounce Sheath | DYB | Substantially Equivalent | Surmodics,Inc. | accessdata.fda.gov |
| October 14, 2022 | K221886 | Sublime Microcatheter | DQY | Substantially Equivalent | Surmodics,Inc. | accessdata.fda.gov |
| June 16, 2021 | K211044 | Sublime Radial Access 018 RX Dilatation Catheter | LIT | Substantially Equivalent | Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, | accessdata.fda.gov |
| December 22, 2020 | K201705 | ReVene Thrombectomy Catheter | QEW | Substantially Equivalent | Vetex Medical, Ltd. | accessdata.fda.gov |
| May 14, 2020 | K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter | LIT | Substantially Equivalent | Creagh Medical, Ltd. | accessdata.fda.gov |
| 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, Angioplasty, Peripheral, Transluminal
- All makers of Catheter, Percutaneous
- All makers of Introducer, Catheter
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
- All makers of Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- All makers of Catheter, Continuous Flush
Updated September 24, 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.