Alcyone MEMS Cannula (AMC) System

FDA 510(k) K150660 · Alcyone Lifesciences, Inc.

Substantially Equivalent

510(k) numberK150660

Submission

Device name
Alcyone MEMS Cannula (AMC) System
Applicant
Alcyone Lifesciences, Inc.
Lowell, MA, US
Received
March 13, 2015
Decision date
April 16, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
HCD – Cannula, Ventricular
Device class
Class I (low risk)
Regulation
21 CFR 882.4060
Specialty
Neurology

Other 510(k)s with product code HCD

510(k)DeviceApplicantDecision
K102101Surgivision MR Compatible Ventricular CannulaHCD · Traditional Surgivision, Inc.01/26/2011SE
K920088Camino Ventricular NeedleHCD · Traditional Camino Laboratories, Inc.05/01/1992SE

More from Camino Laboratories, Inc.

510(k)DeviceDecision
K172006Alivio Ventricular Catheter and Flusher System (Alivio System)JXG · Traditional 11/09/2017SE

Questions and answers

When was Alcyone MEMS Cannula (AMC) System cleared by the FDA?

Alcyone MEMS Cannula (AMC) System (K150660) received a 510(k) decision of Substantially Equivalent on April 16, 2015, 34 days after the submission was received.

What is the product code of K150660?

The FDA product code is HCD – Cannula, Ventricular, a Class I (low risk) device regulated under 21 CFR 882.4060.