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510(k) K010128

COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE by Cook Vascular, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2002
Date Received
January 16, 2001
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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  • 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)
  • K023937 — COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM (May 27, 2003)
  • K022649 — COOK-SWARTZ DOPPLER FLOW PROBE (September 6, 2002)
  • K002958 — SHAPEABLE DOPPLER FLOW PROBE (December 18, 2001)

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