Home / 510(k) Clearances / K081425

510(k) K081425

COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT by Cook Vascular, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2008
Date Received
May 21, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by Cook Vascular, Inc.

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  • K110347 — DOPPLER MONITOR (March 16, 2011)
  • K083482 — COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET (April 2, 2009)
  • 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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  • K232737 — PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp (December 8, 2023)
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  • K181446 — Bard Power-Injectable Implantable Ports (PowerPorts®) (July 8, 2019)
  • K151239 — NMI DUAL PORT II (June 6, 2016)
  • K153359 — BardPort®, SlimPort®, and X-Port® Implanted Ports (May 20, 2016)
  • K153238 — Dignity Dual Port (March 15, 2016)
  • K153228 — NMI Port, NMI Port II (December 4, 2015)