510(k) K171880
K171880 is an FDA 510(k) premarket notification submitted by Irras, Inc. for the device "IRRAflow CNS System". The FDA issued a decision of Substantially Equivalent on Jul 13, 2018. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 13, 2018
- Date Received
- Jun 23, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shunt, Central Nervous System And Components
- Device Class
- Class II
- Regulation Number
- 882.5550
- Review Panel
- NE
- Submission Type
- 510(k)