Penumbra System (Reperfusion Catheter RED 43)
FDA 510(k) K222808 · Penumbra, Inc.
510(k) numberK222808
Submission
- Device name
- Penumbra System (Reperfusion Catheter RED 43)
- Applicant
- Penumbra, Inc.
Alameda, CA, US - Received
- September 16, 2022
- Decision date
- December 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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.
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| K242033 | Access25 Delivery MicrocatheterQJP · Traditional | 12/11/2024SE |
| K242520 | Element Vascular Access SystemDYB · Traditional | 11/20/2024SE |
| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration TubingQEW · Traditional | 09/25/2024SE |
| K242319 | Indigo® Aspiration System Aspiration Catheter 6XQEW · Special | 09/03/2024SE |
Questions and answers
When was Penumbra System (Reperfusion Catheter RED 43) cleared by the FDA?
Penumbra System (Reperfusion Catheter RED 43) (K222808) received a 510(k) decision of Substantially Equivalent on December 20, 2022, 95 days after the submission was received.
What is the product code of K222808?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.