# K260002: Socrates Aspiration System (Socrates 70 Aspiration Catheter)

- Pathway: 510(k) (Traditional)
- Applicant: Scientia Vascular, Inc.
- Decided: Jul 16, 2026 after 195 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)
- K161640: Penumbra System ACE 68 Reperfusion Catheter, Penumbra, Inc. (2016) Summary page 5.

## Indications for use
Socrates Aspiration Catheters As part of the Socrates Aspiration System, the Socrates Aspiration Catheters with a compatible suction pump are 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. Socrates Aspiration Tubing As part of the Socrates Aspiration System, the Socrates Aspiration Tubing is indicated to connect the Socrates Aspiration Catheters to a compatible suction pump.

Source page: https://510kreport.com/device/K260002
Methodology: https://510kreport.com/methodology