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510(k) K090040

RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) by Terumo Medical Corp. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2009
Date Received
January 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Terumo Medical Corp.

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  • K110540 — TERUMO SUPPORT CATHETER (May 13, 2011)
  • K102008 — GLIDESHEATH (July 21, 2010)
  • K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (May 29, 2009)
  • K082997 — TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER (April 15, 2009)
  • K082847 — PINNACLE ROII INTRODUCER SHEATH (October 29, 2008)
  • K082519 — FINECROSS MG CORONARY MICRO-GUIDE CATHETER (September 26, 2008)
  • K082736 — RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER (September 24, 2008)
  • K082644 — GLIDESHEATH (September 18, 2008)

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