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510(k) K022649

COOK-SWARTZ DOPPLER FLOW PROBE by Cook Vascular, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2002
Date Received
August 9, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
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)
  • K010128 — COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE (April 25, 2002)
  • K002958 — SHAPEABLE DOPPLER FLOW PROBE (December 18, 2001)

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