# K230030: Excipio SV Aspiration Catheter and Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Contego Medical, Inc.
- Decided: May 30, 2023 after 145 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142870: Penumbra Embolectomy Aspiration System [INDIGO Aspiration System], Penumbra, Inc. (2015) Summary page 4.

## Indications for use
The Excipio® SV Aspiration Catheter and Tubing is indicated for the non-surgical removal of fresh, soft emboli and thrombi from peripheral blood vessels.

Source page: https://510kreport.com/device/K230030
Methodology: https://510kreport.com/methodology