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510(k) K123605

SMARTFLOW CATHETER by Mri Interventions, Inc. — Product Code HCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2013
Date Received
November 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular
Device Class
Class II
Regulation Number
882.4100
Review Panel
NE
Submission Type

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Other clearances for product code HCA

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  • K021481 — BRESAGEN CATHETER, MODEL CS-3000 (August 6, 2002)
  • K020728 — MIETHKE SHUNT SYSTEM (April 5, 2002)
  • K013005 — ACT 11 MP VENTRICULAR CATHETER (March 8, 2002)
  • K003322 — CODMAN BACTISEAL CATHETERS (October 1, 2001)
  • K992796 — ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 (October 25, 1999)
  • K983331 — MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 (December 16, 1998)
  • K834477 — DISPOS. SCOTT CANNULAS 16-1054 ETC. (March 19, 1984)