# K223530: Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Route 92 Medical, Inc.
- Decided: Apr 11, 2023 after 139 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). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161064: Penumbra System ACE 68 Reperfusion Catheter, Penumbra, Inc. (2016) Summary page 4.

## Recalls of this device
- Mar 8, 2024 · Class I · Z-1611-2024: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

## Indications for use
The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set 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 – 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/K223530
Methodology: https://510kreport.com/methodology