# K211697: Esperance Aspiration Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Wallaby Medical
- Decided: Nov 16, 2021 after 166 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.
1 later device descends from it; 1 cites 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)
- K090752: Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator 054), Model PSS054, Penumbra, Inc. (2009) Summary page 4.
- K142458: Penumbra System ACE, Penumbra, Inc. (2015) Summary page 4.

## Most influential descendants
- K251357: Esperance pHLO Aspiration System (2026), 0 descendants of its own

## Indications for use
The Esperance Aspiration Catheter with the Medela Dominant Flex Surgical Suction Pump and Wallaby Aspiration Tubing set is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral - Ml 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.

Source page: https://510kreport.com/device/K211697
Methodology: https://510kreport.com/methodology