# K223913: Socrates Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Scientia Vascular, Inc.
- Decided: Sep 20, 2023 after 265 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003410 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113163: Penumbra System Max, Penumbra, Inc. (2011) Summary page 4.

## Recalls of this device
- Jan 2, 2025 · Class II · Z-1234-2025: Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.

## Indications for use
As part of the Socrates Aspiration System, the Socrates 38 Aspiration Catheter with a compatible suction pump 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 fail IV t-PA therapy are candidates for treatment. As part of the Socrates Aspiration System, the Socrates Aspiration Tubing is indicated to connect the Socrates 38 Aspiration Catheter to a compatible suction pump.

Source page: https://510kreport.com/device/K223913
Methodology: https://510kreport.com/methodology