Medical Device Manufacturer · US , Lrvine , CA

Ev3 Neurovascular - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2009

Recent clearances: MERIDIAN GUIDEWIRE, HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104, HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ev3 Neurovascular Cardiovascular ✕

3 devices

1-3 of 3

Cleared Jan 26, 2010

MERIDIAN GUIDEWIRE

Cardiovascular · 60d

Cleared Oct 15, 2009

HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM,...

Cardiovascular · 150d

Cleared Sep 22, 2009

HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315

Cardiovascular · 39d