510(k) K190338
K190338 is an FDA 510(k) premarket notification submitted by Inneuroco, Inc. for the device "046 Zenith Flex". The FDA issued a decision of Substantially Equivalent on August 2, 2019. The device falls under product code NRY (Catheter, Thrombus Retriever), a Class II device regulated under 21 CFR 870.1250. Inneuroco, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2019
- Date Received
- February 14, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Thrombus Retriever
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- NE
- Submission Type
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.