Medical Device Manufacturer · US , Fort Lauderdale , FL

Orbusneich Medical Trading, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2018

Recent clearances: Sapphire II PRO, Sapphire NC Plus Coronary Dilatation Catheter, Scoreflex PTA Scoring Balloon Catheter

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orbusneich Medical Trading, Inc. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Mar 04, 2020

Sapphire II PRO

Cardiovascular · 29d

Cleared Sep 19, 2019

Sapphire NC Plus Coronary Dilatation Catheter

Cardiovascular · 21d

Cleared Jun 11, 2019

Scoreflex PTA Scoring Balloon Catheter

Cardiovascular · 257d

Cleared Nov 09, 2018

Teleport Microcatheter

Cardiovascular · 71d

Cleared Jun 28, 2018

Sapphire II PRO Balloon Dilatation Catheter

Cardiovascular · 80d

Cleared CT Mar 01, 2018

Sapphire II PRO

Cardiovascular · 90d

Cleared Feb 09, 2018

Jade PTA Balloon Dilatation Catheter

Cardiovascular · 50d