# K161064: Penumbra System ACE 68 Reperfusion Catheter

- Pathway: 510(k) (Special)
- Applicant: Penumbra, Inc.
- Decided: Jun 12, 2016 after 58 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K003410 (2001). 11 ancestors in all.
15 later devices descend from it; 5 cite it directly.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152541: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters, Penumbra, Inc. (2016) Summary page 4.

## Most influential descendants
- K172167: Zenith Flex System (2018), 7 descendants of its own
- K181354: 074 Zenith Flex System (2018), 6 descendants of its own
- K190212: AXS Vecta Aspiration System (2019), 5 descendants of its own
- K191768: AXS Vecta Aspiration System (2019), 4 descendants of its own
- K193380: CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (2020), 3 descendants of its own

## Indications for use
The Penumbra System is intended 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.

Source page: https://510kreport.com/device/K161064
Methodology: https://510kreport.com/methodology