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510(k) K082519

FINECROSS MG CORONARY MICRO-GUIDE CATHETER by Terumo Medical Corp. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2008
Date Received
September 2, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

Other clearances by Terumo Medical Corp.

  • K111606 — PINNACLE PRECISION ACCESS SYSTEM (October 3, 2011)
  • K111556 — GLIDECROSS SUPPORT CATHETER (July 29, 2011)
  • 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)
  • K090040 — RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) (February 6, 2009)
  • K082847 — PINNACLE ROII INTRODUCER SHEATH (October 29, 2008)
  • K082736 — RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER (September 24, 2008)
  • K082644 — GLIDESHEATH (September 18, 2008)

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