Data / Medical devices / United States / Shape Memory Medical Inc
Shape Memory Medical Inc: FDA-registered device maker in San Jose, CA, United States, 2 510(k) clearances
Shape Memory Medical Inc is registered with the FDA (registration 3013353964) in San Jose, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 23, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013353964
- Address
- 1321 Ridder Park Drive Suite 10, San Jose, CA, United States, 95131
- Owner or operator
- Shape Memory Medical Inc (10055775)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- October 5, 2017
- Registered through
- 2026
- Brand names listed
- IMPEDE Embolization Plug, IMPEDE-FX Embolization Plug, IMPEDE-FX RapidFill, TrelliX Embolic Coil System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Neurovascular Embolization | HCG | 2 | Manufacturer for export | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Manufacturer, Manufacturer for export | 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 |
|---|---|---|---|---|---|---|
| May 23, 2019 | K182390 | IMPEDE-FX Embolization Plug | KRD | Substantially Equivalent | Shape Memory Medical | accessdata.fda.gov |
| June 22, 2018 | K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm | KRD | Substantially Equivalent | Shape Memory Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Vascular, For Promoting Embolization
- All makers of Device, Neurovascular Embolization
Updated May 23, 2019. 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.