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510(k) K150660

Alcyone MEMS Cannula (AMC) System by Alcyone Lifesciences, Inc. — Product Code HCD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2015
Date Received
March 13, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Alcyone Lifesciences, Inc.

  • K172006 — Alivio Ventricular Catheter and Flusher System (Alivio System) (November 9, 2017)

Other clearances for product code HCD

  • K102101 — SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA (January 26, 2011)
  • K920088 — CAMINO VENTRICULAR NEEDLE (May 1, 1992)