Medical Device Manufacturer · US , Elkton , MD

Terumo Medical Corp. - FDA 510(k) Cleared Devices

143 submissions · 143 cleared · Since 1980

143

Total

143

Cleared

0

Denied

FDA 510(k) Regulatory Record - Terumo Medical Corp. Cardiovascular ✕

64 devices

1-12 of 64

Cleared Oct 03, 2011

PINNACLE PRECISION ACCESS SYSTEM

Cardiovascular · 116d

Cleared Jul 29, 2011

GLIDECROSS SUPPORT CATHETER

Cardiovascular · 53d

Cleared May 13, 2011

TERUMO SUPPORT CATHETER

Cardiovascular · 77d

Cleared Jul 21, 2010

Cardiovascular · 5d

Cleared May 29, 2009

PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

Cardiovascular · 24d

Cleared Feb 06, 2009

RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)

Cardiovascular · 31d

Cleared Oct 29, 2008

PINNACLE ROII INTRODUCER SHEATH

Cardiovascular · 30d

Cleared Sep 26, 2008

FINECROSS MG CORONARY MICRO-GUIDE CATHETER

Cardiovascular · 24d

Cleared Sep 24, 2008

RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER

Cardiovascular · 6d

Cleared Sep 18, 2008

Cardiovascular · 7d

Cleared May 28, 2008

DESTINATION RENAL GUIDING SHEATH

Cardiovascular · 44d

Cleared May 21, 2008

PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

Cardiovascular · 37d

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