# K173200: SOFIA Plus Aspiration Catheter

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Jun 11, 2018 after 252 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: 8 generations back to K003410 (2001). 11 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152541: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters, Penumbra, Inc. (2016) Summary page 4.

## Most influential descendants
- K232524: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (2023), 4 descendants of its own
- K242504: Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (2024), 3 descendants of its own
- K250012: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (2025), 1 descendant of its own
- K253901: Millipede88 Access Catheter (2026), 0 descendants of its own
- K252392: Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (2025), 0 descendants of its own

## Indications for use
The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Pump and MicroVention Tubing Kit 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/K173200
Methodology: https://510kreport.com/methodology