# K151623: Penumbra System 110 Aspiration Tubing

- Pathway: 510(k) (Special)
- Applicant: Penumbra, Inc.
- Decided: Aug 6, 2015 after 51 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: 7 generations back to K003410 (2001). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133317: Penumbra System / Penumbra System Max, Penumbra, Inc. (2014) Summary page 5.
- K142458: Penumbra System ACE, Penumbra, Inc. (2015) Summary page 5.

## Most influential descendants
- K182522: Penumbra System (Modified 110 Aspiration Tubing) (2018), 1 descendant of its own
- K250690: Penumbra System (Thunderbolt Aspiration Tubing) (2026), 0 descendants of its own

## Indications for use
The Penumbra System / Penumbra System MAX are 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. 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. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.

Source page: https://510kreport.com/device/K151623
Methodology: https://510kreport.com/methodology