510(k) K122478
K122478 is an FDA 510(k) premarket notification submitted by Concentric Medical, Inc. for the device "MODIFIED TREVO RETRIEVER". The FDA issued a decision of Substantially Equivalent on October 31, 2012. The device falls under product code NRY (Catheter, Thrombus Retriever), a Class II device regulated under 21 CFR 870.1250. Concentric Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2012
- Date Received
- August 14, 2012
- 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.