510(k) K150660
K150660 is an FDA 510(k) premarket notification submitted by Alcyone Lifesciences, Inc. for the device "Alcyone MEMS Cannula (AMC) System". The FDA issued a decision of Substantially Equivalent on April 16, 2015. The device falls under product code HCD (Cannula, Ventricular), a Class I device regulated under 21 CFR 882.4060. Alcyone Lifesciences, Inc. has at least 1 other 510(k) clearance on record.
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