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510(k) K023937

COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM by Cook Vascular, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2003
Date Received
November 26, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K110347 — DOPPLER MONITOR (March 16, 2011)
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  • K081425 — COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT (September 30, 2008)
  • K061000 — EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 (May 10, 2006)
  • K032223 — COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT (October 15, 2003)
  • K022649 — COOK-SWARTZ DOPPLER FLOW PROBE (September 6, 2002)
  • K010128 — COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE (April 25, 2002)
  • K002958 — SHAPEABLE DOPPLER FLOW PROBE (December 18, 2001)

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