# K162901: Penumbra 3D Revascularization Device

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Apr 20, 2017 after 185 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K003410 (2001). 13 ancestors in all.
16 later devices descend from it; 6 cite it directly.
5 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160449: Penumbra System, Penumbra Pump MAX, Penumbra, Inc. (2016) Summary page 4.

## Most influential descendants
- K173761: Penumbra System Reperfusion Catheter JET 7 (2018), 10 descendants of its own
- K211654: Penumbra System (Reperfusion Catheter RED 72) (2021), 3 descendants of its own
- K190010: Penumbra System Reperfusion Catheter JET 7 (2019), 3 descendants of its own
- K203440: Penumbra System (Reperfusion Catheter RED 62) (2021), 2 descendants of its own
- K191946: Penumbra System Penumbra JET 7X (2020), 2 descendants of its own

## Recalls of this device
- Jun 9, 2017 · Class I · Z-2702-2017: Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to s

## Indications for use
Penumbra Reperfusion Catheters and Separators As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral — M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Penumbra 3D Revascularization Device As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-Ml and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Penumbra Aspiration Tubing As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

Source page: https://510kreport.com/device/K162901
Methodology: https://510kreport.com/methodology