Medical Device Manufacturer · US , Santa Clara , CA

Shape Memory Medical - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2018

Recent clearances: IMPEDE-FX Embolization Plug, IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shape Memory Medical Cardiovascular ✕

2 devices

1-2 of 2

Cleared May 23, 2019

IMPEDE-FX Embolization Plug

Cardiovascular · 261d

Cleared Jun 22, 2018

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE...

Cardiovascular · 63d