Penumbra System Reperfusion Catheter JET 7
FDA 510(k) K190010 · Penumbra, Inc.
510(k) numberK190010
Submission
- Device name
- Penumbra System Reperfusion Catheter JET 7
- Applicant
- Penumbra, Inc.
Alameda, CA, US - Received
- January 3, 2019
- Decision date
- June 16, 2019
- 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 JET 7 cleared by the FDA?
Penumbra System Reperfusion Catheter JET 7 (K190010) received a 510(k) decision of Substantially Equivalent on June 16, 2019, 164 days after the submission was received.
What is the product code of K190010?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.