# K180705: Riptide Aspiration System React 68 Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Jul 4, 2018 after 107 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: 9 generations back to K003410 (2001). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have 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.

## Most influential descendants
- K182101: Riptide Aspiration System (React 71 Catheter) (2018), 0 descendants of its own

## 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/K180705
Methodology: https://510kreport.com/methodology