Data / Medical devices / United States / Piraeus Medical, Inc.
Piraeus Medical, Inc.: FDA-registered device maker in Maple Grove, MN, United States, 4 510(k) clearances
Piraeus Medical, Inc. is registered with the FDA (registration 3031768596) in Maple Grove, MN, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 4, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3031768596
- Address
- 7351 Kirkwood Ln N Ste 116, Maple Grove, MN, United States, 55369
- Owner or operator
- Piraeus Medical, Inc. (10092214)
- Roles
- Manufacturer
- First device listed
- December 13, 2024
- Registered through
- 2027
- Brand names listed
- 35 Helix Guidewire, 70 NeuGlide Catheter, 87 NeuGlide Catheter, 87 NeuGlide+ Catheter, 93 NeuFlex Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Neurovasculature | QJP | 2 | Manufacturer | accessdata.fda.gov |
| Guide, Wire, Catheter, Neurovasculature | MOF | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 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 |
|---|---|---|---|---|---|---|
| September 4, 2026 | K262277 | 70 NeuGlide Catheter | QJP | Substantially Equivalent | Piraeus Medical, Inc. | accessdata.fda.gov |
| August 27, 2026 | K260751 | 35 Helix Guidewire | MOF | Substantially Equivalent | Piraeus Medical, Inc. | accessdata.fda.gov |
| May 23, 2025 | K251044 | 93 NeuFlex Catheter | QJP | Substantially Equivalent | Piraeus Medical | accessdata.fda.gov |
| December 6, 2024 | K240971 | 87 NeuGlide Catheter | QJP | Substantially Equivalent | Piraeus Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous
- All makers of Catheter, Percutaneous, Neurovasculature
- All makers of Wire, Guide, Catheter
- All makers of Guide, Wire, Catheter, Neurovasculature
Updated September 4, 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.