Alcyone MEMS Cannula (AMC) System
FDA 510(k) clearance K150660 · decided 2015-04-16
Clearance details
- K-number
- K150660
- Device name
- Alcyone MEMS Cannula (AMC) System
- Applicant
- Alcyone Lifesciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-13
- Decision date
- 2015-04-16
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- HCD
- Device class
- 1
- Regulation number
- 882.4060
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Lowell, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA (K102101) | Surgivision, Inc. | 2011-01-26 |
| CAMINO VENTRICULAR NEEDLE (K920088) | Camino Laboratories, Inc. | 1992-05-01 |
Recalls involving this device
No recalls on record reference this clearance.