# K190338: 046 Zenith Flex

- Pathway: 510(k) (Traditional)
- Applicant: Inneuroco, Inc.
- Decided: Aug 2, 2019 after 169 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: 6 generations back to K003410 (2001). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113163: Penumbra System Max, Penumbra, Inc. (2011) Summary page 5.

## Most influential descendants
- K241221: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (2024), 1 descendant of its own
- K262398: CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set (2026), 0 descendants of its own
- K252046: Zoom System (Zoom 4S Catheter) (2025), 0 descendants of its own

## Indications for use
The Zenith Flex Aspiration System, including the 046 Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated 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 failed IV t-PA therapy are candidates for treatment.

Source page: https://510kreport.com/device/K190338
Methodology: https://510kreport.com/methodology