510(k) K192289
K192289 is an FDA 510(k) premarket notification submitted by Irras USA, Ltd. for the device "IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit". The FDA issued a decision of Substantially Equivalent on November 15, 2019. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Irras USA, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2019
- Date Received
- August 23, 2019
- 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