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510(k) K102101

SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA by Surgivision, Inc. — Product Code HCD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2011
Date Received
July 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Ventricular
Device Class
Class I
Regulation Number
882.4060
Review Panel
NE
Submission Type

Other clearances by Surgivision, Inc.

  • K100836 — CLEARPOINT SYSTEM (June 16, 2010)
  • K091343 — MRI NEURO DRAPE (September 22, 2009)
  • K091439 — HEAD FIXATION ARC AND TABLE BASE (August 25, 2009)

Other clearances for product code HCD

  • K150660 — Alcyone MEMS Cannula (AMC) System (April 16, 2015)
  • K920088 — CAMINO VENTRICULAR NEEDLE (May 1, 1992)