# K183185: Riptide Aspiration System (Riptide Large Bore Aspiration System)

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Dec 18, 2018 after 29 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: 10 generations back to K003410 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172448: Riptide Aspiration System, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2017) Summary page 4.

## Indications for use
The Riptide™ Aspiration 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. 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/K183185
Methodology: https://510kreport.com/methodology