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510(k) K141148

EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET by Cook Vascular, Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2014
Date Received
May 5, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

Other clearances by Cook Vascular, Inc.

  • K142301 — Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sh (November 12, 2014)
  • K110347 — DOPPLER MONITOR (March 16, 2011)
  • K083482 — COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET (April 2, 2009)
  • 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)
  • K023937 — COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM (May 27, 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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