510(k) K211654
K211654 is an FDA 510(k) premarket notification submitted by Penumbra, Inc. for the device "Penumbra System (Reperfusion Catheter RED 72)". The FDA issued a decision of Substantially Equivalent on Aug 16, 2021. The device falls under product code NRY (Catheter, Thrombus Retriever), a Class II device regulated under 21 CFR 870.1250. Penumbra, Inc. has 86 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 16, 2021
- Date Received
- May 28, 2021
- 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
- 510(k)
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.